Support Care Cancer (2006) 14: 802–817DOI 10.1007/s00520-006-0063-4 REVIEW ARTICLE

Amanda BolderstonNancy S. LloydRebecca K. S. WongLori HoldenLinda Robb-Blendermanand the Supportive Care GuidelinesGroup of Cancer Care OntarioProgram in Evidence-based Care

Received: 30 November 2005Accepted: 9 March 2006Published online: 7 June 2006# Springer-Verlag 2006

The prevention and management of acute skin

reactions related to radiation therapy:

a systematic review and practice guideline

Abstract Goals of work: To developa practice guideline report on thequestions: What are the optimalmethods to prevent acute skin reac-tions (occurring within the first6 months of irradiation) related toradiation therapy? What are the op-timal methods to manage acute skinreactions related to radiation thera-py? Materials and methods: CancerCare Ontario’s Supportive CareGuidelines Group (SCGG) conducteda systematic review of literature onthis topic. Evidence-based recom-mendations were formulated to guideclinical decision making, and a formalexternal review process was con-ducted to validate the relevance ofthese opinions for Ontario practi-tioners. Main results: Twenty-eighttrials meeting the inclusion criteriawere identified. Of the twenty-threetrials that evaluated preventativemethods, washing was the only prac-

tice which significantly preventedskin reaction. Some evidence sug-gested topical steroid creams andcalendula ointment might be effective.None of the five trials evaluating skinreaction management detected a pos-itive effect using steroid cream, su-cralfate cream, or dressings.Conclusions: Skin washing, includ-ing gentle washing with water alonewith or without mild soap, should bepermitted in patients receiving radia-tion therapy to prevent acute skinreaction. There is insufficient evi-dence to support or refute specifictopical or oral agents for the preven-tion or management of acute skinreaction. In the expert opinion fromthe SCGG, the use of a plain, non-scented, lanolin-free hydrophiliccream may be helpful in preventingradiation skin reactions. In addition, alow dose (i.e., 1%) corticosteroidcream may be beneficial in thereduction of itching and irritation.

Keywords Practice guideline .Systematic review . Acute skinreactions . Radiation therapy

Introduction

Of the 135,000 Canadians who develop cancer each year,half will receive radiation therapy as part of their treatment[10]. Acute skin reaction is one of the most common sideeffects of radiation therapy. In the context of skin reaction,acute is defined as occurring within the first 6 months ofirradiation [34]. The severity of radiation skin reaction is

graded on a continuum ranging from erythema and drydesquamation to the more severe moist desquamation, andeventually, ulceration. As erythema is not usually experi-enced until radiation doses of around 2,000 cGy [23],patients having palliative treatment at low doses will likelynot exhibit any skin reaction and may, therefore, not needany specialized skin care instructions.

A complete list of Supportive Care Guide-lines Group members is available at: http://www.cancercare.on.ca/.

A. Bolderston . R. K. S. Wong (*)Department of Radiation Oncology,Princess Margaret Hospital,610 University Avenue,Toronto, Ontario M5G 2M9, Canadae-mail: Rebecca.Wong@rmp.uhn.on.caTel.: +416-946-2126Fax: +416-946-4586

N. S. LloydMcMaster University/Cancer CareOntario Program in Evidence-basedCare,1280 Main Street West, DTC, 3rdFloor,Hamilton, Ontario L8S 4L8, Canada

L. HoldenDepartment of Radiation Therapy,Toronto-Sunnybrook Regional CancerCentre,2075 Bayview Avenue,Toronto, Ontario M4N 3M5, Canada

L. Robb-BlendermanKingston General Hospital/CancerCentre of Southeastern Ontario,25 King Street West,Kingston, Ontario K7L 5P9, Canada

A study by Barkham [2] conducted in the UnitedKingdom revealed that 52% of radiation therapy centerssaw dry desquamation as a frequent occurrence and 85%saw moist desquamation as an occasional event. Theprimary aims for managing dry desquamation are toalleviate patient discomfort as there is no skin breakdownand potential for infection. To reduce itching and skinirritation, a moisturizing cream or lotion can be recom-mended. The opposite is true for moist desquamation. Theskin becomes open and susceptible to infection, andantibacterial or antifungal medication with or withoutsoaks and dressings are often currently prescribed. How-ever, when there is no proven infection, the routine use ofantiseptics, antibiotics, and disinfectants is questionable.

Skin care for radiation therapy patients can be acontroversial subject as practices differ considerablybetween institutions and often also between individualpractitioners. A Canadian survey [3] found considerabledifferences between institutions in the prevention andmanagement of acute radiation skin reactions. Inconsis-tencies between practitioners can lead to patients receivingconflicting or even erroneous, information. Areas whereopinions differ are in allowing the use of washing, soap,creams, or deodorants and in the management of dry andmoist desquamation, the use of steroid creams, salinesoaks, gel or occlusive dressings, or topical antibiotics.

Restrictive skin care practices that interfere with normalhygiene can be very distressing to the patient. When askedto suspend normal hygiene practices, the patient may feelsocially unacceptable at a time when the maintenance ofexisting social support is very important [9]. Suchrestrictions may also hinder attempts to establish newsupports to help deal with their diagnosis. Social supportfrom family, friends, work colleagues, health care profes-sionals, and the patient’s community is vital for healthy andadaptive adjustment to a cancer diagnosis [42].

Traditional reasons for restricting the use of soaps,creams, lotions, and deodorant on the skin are twofold.First, the addition of a layer of product on the skin wasthought to produce a bolus effect (where the presence ofsignificant additional material on the skin increases thesurface radiation dose). Second, the presence of metallicelements may produce secondary radiation on the skinsurface, which also increases the skin surface dose. A studyby Burch [7], however, that tested a variety of commonlyused skin care products and deodorants (some containingzinc and aluminum), concluded that skin reactions shouldnot increase if those agents are applied during treatmentand that there is no significant bolus effect with normal useof the products using modern megavoltage radiationtherapy equipment.

Due to the inconsistencies in the clinical managementand prevention of acute radiation skin reactions, theSupportive Care Guidelines Group (SCGG) found itimportant to summarize the data from comparative studies.

Materials and methods

Guideline development

This practice guideline report was developed by CancerCare Ontario’s Program in Evidence-based Care (PEBC),using the methods of the Practice Guidelines DevelopmentCycle [6]. This cycle consists of the following four maincomponents: a systematic review of the evidence (methodsdescribed in the next section) and interpretation of the data,external review by Ontario practitioners, approval by thePractice Guideline Coordinating Committee (PGCC)before dissemination, and regular updates of the documentas new evidence becomes available.

Evidence was selected and reviewed by one radiationtherapist (AB) of the PEBC’s SCGG and onemethodologist(NL). Members of the SCGG disclosed potential conflict ofinterest information, and no conflicts were declared.

Methods of the systematic review

Literature search strategy

A search of PreMEDLINE, MEDLINE, CANCERLIT, andthe Cochrane Library (2004, Issue 1) was conducted toidentify comparative studies published between 1980 andApril 2004. Relevant articles were identified by combiningterms and phrases related to skin and specific skinconditions with radiation therapy terms and combiningthese terms with terms specific to the study design. TheMeSH terms “dermis”, “epidermis”, and “skin/re” (radia-tion effects) and text words and phrases “erythema”,“radiation dermatitis”, “radiodermatitis”, “desquamation”(dry and moist), and “acute skin reaction” were combinedwith search terms for radiation therapy including “exploderadiotherapy”, “radiotherapy/ae” (adverse effects), and atext word search for “radiotherapy” or “radiation therapy”.These terms were then combined with the search terms forthe following publication types: practice guidelines, sys-tematic reviews, meta-analyses, reviews, randomized con-trolled trials, controlled clinical trials, and comparativestudies.

In addition, conference proceedings of the meetings ofthe American Society of Clinical Oncology (ASCO) weresearched for abstract reports published between 1997 and2003. The Canadian Medical Association Infobase (http://www.mdm.ca/cpgsnew/cpgs/index.asp) and the NationalGuidelines Clearinghouse (http://www.guideline.gov/)were also searched for existing evidence-based practiceguidelines. Relevant articles and abstracts were selectedand reviewed by two reviewers, and the reference lists fromthese sources were searched for additional trials, as werethe reference lists from relevant review articles.

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Eligibility criteria

Articles were selected for inclusion if they were fullypublished or published abstracts of systematic reviews,meta-analyses, evidence-based practice guidelines, orcomparative studies comparing skin care practices admin-istered by any route for the prevention or treatment of acuteskin reactions due to radiation therapy. Trials consideredfor inclusion must have reported the degree of skin reaction(using a validated skin reaction score), which was theprimary outcome of interest. Secondary outcomes ofinterest included pain, itchiness, burning, quality of life,and toxicities. Data must have been collected prospectivelyin at least one arm of the trial. Historical controls werepermitted. Letters, comments, and editorials were excludedas were articles published in a language other than English.

Synthesizing the evidence

Meta-analysis was not performed because the includedtrials were too clinically heterogeneous, mainly as theyevaluated different treatment regimens. In addition, mosttrials were too heterogeneous in terms of outcomeassessment and reporting of results. For some interven-tions, only one trial was identified, thereby, eliminating thepossibility of pooling.

Results

Literature results

No systematic reviews, meta-analyses, or evidence-basedpractice guidelines were identified. Two practice guide-lines, one by the British Columbia Cancer Agency [5] andone by the Oncology Nursing Society [33] were identified;however, the recommendations in both guidelines werebased on expert opinion and consensus rather than asystematic review of the evidence, and therefore, did notmeet the eligibility criteria. Five trials deemed ineligible forthis review were excluded because one was a phase IInoncomparative study [44], one did not report the degree ofskin reaction as a primary outcome of interest [24], one wascompletely retrospective [25], and two trials had not used avalidated scale to assess the degree of skin reaction [1, 41].

Twenty-eight trials meeting the inclusion criteria wereidentified [4, 8, 11–16, 18–22, 26–32, 35–40, 45, 46].Twenty-three trials were aimed at prevention of skinreaction [4, 8, 11, 13–16, 18–20, 22, 26–28, 30–32, 35, 38–

40, 45, 46], and five trials were concerned with manage-ment of existing skin reaction [12, 21, 29, 36, 37].Descriptions of all trials, including treatment regimens andoutcomes are provided in Tables 1, 2, 3.

Study quality

The variety of interventions assessed made it difficult tothoroughly evaluate individual interventions. The availableevidence varied greatly in methodology, clinical outcomesmeasured, tumor sites evaluated, radiation therapy regi-mens, and sample population sizes, which were often small.

Twenty five of the 28 trials were randomized controlledtrials (RCTs). Of those, 20 had the patient as the unit ofrandomization [4, 8, 11, 12, 15, 16, 18, 21, 22, 26, 27, 31,32, 35, 37–40, 45, 46], and five used treatment side as theunit of randomization [14, 19, 28–30]. Of all 28 includedtrials, nine were either double, triple, or quadruple-blind [4,12, 14, 19, 21, 26, 27, 30, 38], six were single-blind [22,28, 29, 32, 35, 37], and nine did not incorporate blindingmethods [8, 11, 15, 16, 18, 31, 39, 40, 45]. One studyexamined two separate trials, where one was double-blinded and the other did not incorporate a blinding method[46]. Three nonrandomized trials met the eligibility criteria[13, 20, 36]. Two of those did not incorporate blinding inthe study design [13, 20], and the other was double-blind[36]. One open trial evaluated patients in the experimentaltreatment prospectively but used a historical control groupfor comparison [20]. Blinding methods and how randomi-zation was achieved were not always well described in theprimary reports.

Only four trials used an intention-to-treat approach to dataanalysis [8, 28, 37, 45], while 21 trials analyzed evaluablepatients only [4, 11–16, 18–22, 26, 27, 30–32, 35, 38–40]. Acommonly cited reason for excluding patients from the finalanalysis was poor compliance to treatment. One smallintraindividual comparison simply presented a description ofthe results without statistical analysis [36]. In most trials, asingle outcome assessment was made, usually by a radiationtherapist, dermatologist, physician, research nurse, radiolo-gist, or the primary investigator [4, 8, 12, 13, 15, 19, 22, 28,30, 32, 35–37, 40]. Some trials, however, did not adequatelyreport on how outcome assessments were conducted [11, 14,16, 18, 27, 39, 45]. Independent outcome assessments weremade by two or more assessors in four trials [20, 21, 26, 38].Inter-rater reliability scores and kappa scores were calculatedin only one trial [21]. One trial compared outcomeassessments made by the attending physician or oncologynurse with assessments made by the patients [31].

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Table 1 Study descriptions and outcomes of trials on the prevention of acute radiation skin reactions

Author,Year(Ref)

No.ofpts1

Treatment Arms2 Outcomes Assessed Study Design/Unit ofRandomization/Blinding

Skin reaction Pain Itching

Topical steroid creamsBostrom2001 [4]

2525

0.1% MMF + emollientemollient

Max erythema score, p=0.011; totalerythema index, p=0.0033 in favourof MFF

p=0.42 p=0.069 infavour of MFF

RCT/patient/double-blind

Schmuth2002[38]

1211

0.1% MPA0.5% dexpanthenol

Mean severity score: p=0.1 NA MPA arm: 2 ptsDex arm: 1 pt

RCT/patient/double-blind

Løkkevik1996[28]

86 Dexpanthenol(Bepanthen)3

cream vs. no cream

Erythema grade: p=1.00 p=0.56 p=0.43 RCT/treatmentside/single-blind

Desq grade: p=0.027 in favour of dexat 6 wk

Washing practicesRoy 2001[37]

(49) No washing Max erythema score: NS p>0.05 p>0.05 RCT/patient/single-blind

(50) Washing with soap +water

Max moist desq score: washing grp7 pts (14%) vs. non-washing group16 pts (33%); p=0.03

Campbell1992 [8]

(14) Bolus4; no washing Mean erythema score: p<0.05 at 6 &8 wks in bolus and no bolus grps,respectively, in favour of washingwith soap + water vs. no washing

NS Mean itchingscore: p<0.05in favour ofsoap + water

RCT/patient/open

(14) Bolus; washing withwater

(16) Bolus; washing withsoap + water

(14) No bolus; no washing(21) No bolus; washing

with soap(16) No bolus; washing

with soap + waterWestbury2000[45]

5455

No hair washing (avoid)Normal hair washingroutine

Degree of erythema/desq: p>0.05 p>0.05 p>0.05 RCT/patient/open

Sucralfate or sucralfate derivativesLievens1998[26]

(38)(45)

Oral sucralfatePlacebo

Time to mean dermatitis scores: NS(p value NR)

NA NA RCT/patient/double-blind

Evensen2001[14]

60 NaSOS gel vs.placebo

Mean erythema score: p=0.1335 Mean score:p=0.2584

Mean score:p=0.8546

RCT/treatmentside/double-blind

Mean desq score: p=0.0172 infavour of placebo

Maiche1994[30]

50 sucralfate cream vs.placebo

G2 rxn: p=0.01 at 4 wks & p<0.05at 5 wks in favour of sucralfate

NA No statisticalanalysis

RCT/treatmentside/double-blind

805

Author,Year(Ref)

No.ofpts1

Treatment Arms2 Outcomes Assessed Study Design/Unit ofRandomization/Blinding

Skin reaction Pain Itching

Biafine creamFenig2001[15]

252425

Biafine ointmentLipderm ointmentNo treatment

Degree of skin rxn: p=0.98 (nurse’sgrading); p=0.15 (radiotherapist’sgrading)

NA NA RCT/patient/open

Fisher2000[16]

(66)(74)

Biafine ointmentBest supportive care5

Max skin rxn score: p=0.77; time to G2toxicity: p=0.44; duration ofdermatitis: P=0.11

p=0.48 NA RCT/patient/open

Pommier2004[35]

126128

Calendula ointmentBiafine cream

Acute skin toxicity ≥ G2: 41% vs. 63%(p<0.001) in favour of calendula

Mean maxpain:1.54 vs.2.10(p=0.03) infavour ofcalendula

NA RCT/patient/single-blind

Oral enzymesGujral2001[18]

5347

Wobe-Mugos enzymeNo Treatment

Mean max extent of skin rxn: 1.2enzyme vs. 2.4 control; p<0.001 infavour of enzyme ≥ G2 skin rxn: 34%enzyme vs. 76% control; p=0.0016 infavour of enzyme

NS NS RCT/patient/open

Dale2001[11]

6060

Wobe-Mugos enzymeNo Treatment

Mean max extent of skin rxn: 0.97enzyme vs. 1.68 control; p<0.001 infavour of enzyme ≥ G2 skin rxn: 22%enzyme vs. 57% control; p=0.00086infavour of enzyme

NA NA RCT/patient/open

Kaul1999[22]

2525

Wobe-Mugos enzymeNo Treatment

Degree of skin rxn and biopsy scores:p<0.05 in favour of enzyme ≥ G2 skinrxn at week 6: 28% enzyme vs. 88%control (p<0.01 in favour of enzymeover all grades of skin rxn at weeks 3through 11). G4 skin rxn, 4%, 20%,and 40% for control at weeks 6,7, and8 vs. 0% for enzyme

NA NA RCT/patient/single-blind

AmifostineDunst2000[13]

15

15

Radiochemotherapy7

with IV amifostineRadiochemotherapywithout amifostine

Max erythema score: 0.87±0.52amifostine vs. 1.47±0.64 control;p=0.009 in favour of amifostine G2skin rxn: 7% amifostine vs. 53%control. No G3/4 rxns

NA NA non-randomizedcontrolled trial/patient/open

Table 1 (continued)

806

Author,Year(Ref)

No.ofpts1

Treatment Arms2 Outcomes Assessed Study Design/Unit ofRandomization/Blinding

Skin reaction Pain Itching

Topical acid creamLiguori1997[27]

7064

Hyaluronic acid creamPlacebo

Skin rxn score: p<0.01 wks 3–7;p<0.05 wks 8 & 10 in favour of HAcream

NA NA RCT/patient/double-blind

Halperin1993[19]

84 Ascorbic acid cream vs.placebo

Mean toxicity score: p=0.10 NA NA RCT/treatmentside/double-blind

Aloe veraHeggie2002[21]

(107)(101)

Aloe vera creamAqueous cream

Erythema: NS; moist desq: NS; drydesq: p<0.001 in favour of control(higher cumulative probability in aloevera arm, 70% vs. 41%)

≥ G2 painhigherin aloe veraarm(26% vs.17%,p=0.03)

p<0.05 RCT/patient/double-blind

Olsen2001[32]

33

40

mild soap + aloevera gelMild soap

Time to erythema, p=0.948 NA Time to skinitch, p=0.117

RCT/patient/single-blind

Williams1996[46]

97975454

Aloe vera gelPlaceboAloe vera gelNo treatment

Max severity of skin rxn: Trial 1:p=0.36; Trial 2: p=0.31

NA NA RCT/patient/double-blind(trial 1)/open(trial 2)

Chamomile cream vs. Almond ointmentMaiche1991[29]

50 Chamomile cream vs.almond ointment

Frequency of G1, G2 or G3 skin rxn:NS (p value NR)

No statisticalanalysis

No statisticalanalysis

RCT/treatmentside/single-blind

DressingsHazuka1997[20](abstract)

(54)(10)

PASSNo treatment (historicalcontrol)

19/55 treated sites (35%) had ≥ G2desq; treatment; treatmentinterruptions: 1.8% vs. 24% in favourof PASS

NA NA non-randomizedcontrolled trial/patient/open(historicalcontrol)

Notes: desq, desquamation; dex, dexpanthenol; G, Grade; GV, gentian violet; grp, group; HA, hyaluronic acid; IV, intravenous; max,maximum; MMF, mometasone furoate cream; MPA, methylprednisolone aceponate; MVP, moisture vapor permeable; NA, not assessed;NaSOS, Na-sucrose octasulfate; No., number; NR, not reported; NS, not statistically significant; PASS, Polymer Adhesive SkinSealant; pt(s), patient(s); RCT, randomized controlled trial; Ref, reference; rxn, reaction; vs., versus; wk(s), week(s)1Numbers in parentheses indicate evaluable patients; where a single number is presented under no. of patients, the identical patientswere used in each study arm (i.e. intraindividual comparison where the treatment side was the unit of randomization)2Treatment arms listed in order of treatment arm versus control arm3Concentration of dexpanthenol not reported4Patients received 1 cm Vaseline bolus applied between 10–15 fractions of the 20-fraction course5Institution’s product of choice at time of randomization (31% Aquaphor, 34% aloe vera, 19% other, 16% no treatment)6Reviewer’s analysis of difference in proportions7Six courses of 5-fluorouracil (5-FU)

Table 1 (continued)

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Outcomes

Acute skin reaction, pain and itching (Table 1)

Studies on prevention on acute skin reaction

Topical steroid creams

Three trials evaluated steroid creams for the prevention ofacute skin reaction [4, 28, 38]. None of the trials had thesame treatment groups, limiting comparison between trials.Although the trial was relatively small, Bostrom [4]detected a significant benefit in favor of 0.1% mometasonefuroate cream in terms of lower maximal erythema scoresand grade 4 or greater skin reaction (6/24 patients, 25%, vs15/25, 60%). In an intraindividual comparison (wherepatients served as their own controls) of dexpanthenolcream vs no treatment, Løkkevik reported no clinicallyrelevant differences between groups [28]. In that trial, skinreactions were most severe for all patients at the sixth visit,which served as the reference time point for evaluation.Schmuth [38] randomized 0.1% methylprednisolone ace-ponate (MPA) (Advantan) cream vs 0.5% dexpanthenolcream and found no significant difference in the degree ofskin reaction between patients. In comparison to anonrandomized control group, neither cream was success-ful in preventing radiation dermatitis, as 19 of the 21patients developed radiation skin reactions (76% ≥Grade 2;38% ≥Grade 4); however, fewer patients in the MPA grouphad severity scores ≥4 compared to the dexpanthenol group(p<0.05). None of the trials detected a significant differencebetween groups in patients’ experience of pain or itching.

Washing practices

Three moderately-sized RCTs compared washing the skinor hair to not washing during radiation therapy [8, 37, 45].The two trials assessing skin washing both detected lesssevere skin reactions in the washing groups [8, 37]. Thetrial byWestbury [45], however, did not detect a significantdifference in skin reaction between hair-washing practicesin patients receiving cranial irradiation. Patients in thecontrol group reported presence of distress but thatoutcome was not evaluated in patients who followed anormal hair care regimen. Pain and itchiness was assessedin all three trials. None of the trials reported significantdifferences in pain scores, and only one trial reported loweraverage scores for itchiness for the washing groupscompared to the non-washing group [8].

While no significant difference in maximal erythemascore was detected in the trial by Roy [37], there was asignificant difference in the incidence of moist desquama-tion in favor of washing compared with no washing. Fewer

patients in the washing group received prior or concomitantchemotherapy than in the non-washing group but thatdifference was not significant. Patients in the washinggroup did not all follow the same washing regimen, and awide variety of soaps were used. Patients included in thestatistical analysis comprised both those who compliedwith the washing policy and those who did not. There wasno significant difference in the mean time to reach maximaltoxicity.

Campbell [8] randomized patients to one of three groups(no washing, washing with water, or washing with soapand water). Patients were also categorized into one of twononrandomized groups; those that applied a 1-cm Vaselinebolus to the skin between 10 and 15 fractions of the 20fraction course (n=44), and those that did not apply theVaseline bolus (n=51). Average washing frequency was11.9 times per week (range: 7–28). Erythema scores weresimilar for the two washing groups, regardless of bolus; thenon-washing groups tended to have higher erythemascores, particularly in the Vaseline bolus group (statisticallysignificant at weeks 6 or 8). Average desquamation scoresfollowed a similar pattern, with statistically significantlylower desquamation scores in both washing groups at8 weeks. Although the data presented in the full reportincluded only the average scores, the authors reported thatmaximum reactions showed similar results.

Sucralfate/sucralfate derivatives

Three randomized trials compared topical [14, 30] or oral[26] sucralfate against a placebo in head and neck [14, 26]or breast cancer [30] patients with conflicting outcomes. Ofthe two intraindividual trials, only one detected a signif-icant benefit in erythema incidence for sucralfate cream[30], although the other trial detected a significantdifference in mean desquamation scores in favor of theplacebo cream [14]. Lievens [26] reported no significantreduction in dermatitis with oral sucralfate compared with aplacebo. Comparability of the trial results is limited byvariation in the patient populations, differences in routes oftreatment administration, and composition of the sucralfatecream. Only one of the trials provided statistical data onpain and itching and reported no significant differences inmean scores between groups [14].

Biafine cream

Two randomized non-blinded trials assessed the effective-ness of topical Biafine cream [15, 16], and one randomizedsingle-blind trial compared calendula ointment to Biafinecream [35]. Biafine, an oil-in-water emulsion withnonsteroidal anti-inflammatory properties, is commonlyused for radiation-induced dermatitis. The chemicalcomposition has been well described elsewhere [44].

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Fisher compared Biafine to best supportive care (BSC)[16]. BSC was defined as the institution’s product ofchoice, with 31% of patients receiving Aquaphor, 34% aloevera, 19% other therapy, and 16% receiving no skin careproduct. There were no significant differences in the degreeof skin reaction in the trials by Fenig and Fisher [15, 16].

In the largest randomized trial aimed at prevention ofacute radiation dermatitis, Pommier [35] compared calen-dula ointment with Biafine cream in 254 breast cancerpatients and found that patients in the calendula group hadsignificantly fewer occurrences of ≥Grade 2 dermatitis(p<0.001) and greater pain relief (p=0.03). However,patients reported significantly greater difficulty in theadministration of calendula vs Biafine (30 vs 5%), with twopatients discontinuing treatment because of that difficulty.

Oral enzymes

Three RCTs compared the efficacy of oral hydrolyticenzymes vs no treatment in reducing acute skin reaction in

patients with head and neck cancer [18, 22] or cervicalcancer [11]. Two trials were open label [11, 18], and oneblinded the pathologist assessing pre- and post-radiationtherapy biopsies but not the person conducting skinassessments [22]. Although the trial by Kaul [22] wasreported as a study aimed at management of acute radiationreactions, as eligible patients did not have existing skinreactions before the start of enzyme therapy and enzymetreatment began at the start of radiation therapy, that trialwas categorized as a prevention trial.

All groups were well balanced at baseline, and all threetrials detected a significant benefit in favor of enzymetherapy. The most clinically significant outcome, namely,≥Grade 2 skin reaction, was found to be significantly lowerin the enzyme group as reported in the trial [22] orcalculated by the guideline authors [11, 18]. In the trial byKaul [22], significant differences in favor of enzymetherapy were also reported in terms of pre- and post-radiation therapy biopsy scores, although the cut-off scores(reported as + and − ranks) were not clearly reported.

Table 2 Study descriptions and outcomes of trials on the management of acute radiation skin reactions

Author,year(Ref)

No.ofpts1

Treatment arms2 Outcomes assessed Study design/unit ofrandomization/blinding

Skin reaction Pain Itching

Topical steroid creamsSchreck2002[39]

12 Cream (Linola® orBepanthen®) vs.Powder

No statistical analysis No statistical analysis Nostatisticalanalysis

RCT/patient/open

Potera1982[36]

21 0.2% hydrocortisonevalerate cream vs.placebo

Erythema, dry/moist desq,ulceration, duration/intensityof symptoms: NS

NA NA Nonrandomizedcontrolled trial/treatment-side/double-blind

Sucralfate or sucralfate derivativesDelanay1997[12]

20 10% sucralfate insorbolene cream

Mean time to healing, sucralfate14.8 days vs. control 14.2 days,p=0.86

Mean changes in paingrade: p=0.32

NS RCT/patient/quadruple-blind

19 Sorbolene cream (control)DressingsShell1986[40]

10 Moisture VaporPermeable dressing(Tegaderm®)

Mean healing time: 19(MVP) vs. 24 days; p>0.05

NS NA RCT/patient/open

11 Hydrous lanolin gauzeMak2000[31]

(21) Moist hydrocolloiddressing

Mean healing time: 11.42 vs. 11.7(GV) days; p=0.83

Severity & frequencyp=0.012, p=0.03 in favourof control

NA RCT/patient/open

(18)3 Topical gentian violet

desq Desquamation, GV gentian violet, MVP moisture vapor permeable, NA not assessed, NS not statistically significant, RCT randomizedcontrolled trial, vs. versus1Numbers in parentheses indicate evaluable patients; where a single number is presented under no. of patients, the identical patientswere used in each study arm (i.e. intraindividual comparison where the treatment side was the unit of randomization)2Treatment arms listed in order of treatment arm versus control arm3Analysis was based on 33 versus 32 wounds for moist hydrocolloid and topical gentian violet, respectively

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Table 3 Tumour type, radiation therapy regimen, adjuvant treatments or co-interventions

Author,year (Ref)

Tumour type Radiation therapy regimen1 Adjuvant treatments/Co-interventions

Post-operative(+)

Chemotherapy(+/−)

Additional skincare agents used

Prior Concomitant

Prevention trialsTopical steroid creamsBostrom 2001[4]

Breast 54 Gy in 27#; 5 MV + NR − +2

Schmuth 2002[38]

Breast 56 Gy in 28#; 8 MV + + + −

Løkkevik 1996[28]

Breast &Larynx

B: 50 Gy in 25#; 5 MV or Cobalt 60;6–12 MeV; L:70 Gy in 35#; 5 MV

+3 + +3 NR

Washing practicesRoy 2001 [37] Breast 45 Gy in 20# of 2.25 Gy or 50 Gy in

25# of 2 Gy;Cobalt 60 or 6 MV

NR NR NR −

Campbell 1992[8]

Breast 45–47 Gy in 20#; 5 MV + − − +4

Westbury 2000[45]

Brain High dose (>30 Gy) or low dose (≤30 Gy) NR NR NR −

Sucralfate or sucralfate derivativesLievens 1998[26]

H & N 55–66 Gy in 25–33#; Cobalt 60 or 6 MV NR NR NR NR

Evensen 2001[14]

H & N 50–70 Gy in 25–35#; 4–6 MV NR NR NR NR

Maiche 1994[30]

Breast 50 Gy in 25#; 6 MeV + NR NR NR

Topical BiafineFenig 2001 [15] Breast 50 Gy in 25#; 6 MV + − − +5

Fisher 2000[16]

Breast 50–64 Gy NR NR − −

Pommier 2004[35]

Breast 52 Gy in 10#; 5 MV (lumpectomy pts) + + − −6

46 Gy; optional 10 Gy boost (mastectomy pts)Oral enzymesGujral 2001[18]

H & N 50–70 Gy in 25–35#; Cobalt 60 NR + NR −

Dale 2001 [11] UterineCervix

50–60 Gy in 25#; brachytherapy boost at20–30 Gy

NR − NR +7

Kaul 1999 [22] H & N 50–60 Gy in 25–35# NR − NR NRAmifostineDunst 2000 [13] Stage II/III rectal 56 Gy in 31# + + + NRTopical acid creamLiguori 1997[27]

H & N, Breast,Pelvis

H & N: 66 (1.8–2 Gy/#)–81 (1.15 Gy/#)Gy;<6 MV;<10 MeV; B: 60–66 Gy (30–33#);<10 MV;<15 MeV; P: 60–66 Gy (30–33#);15 MV

NR NR − −

Halperin 1993[19]

Brain8 14–70 Gy NR NR NR NR

Aloe veraHeggie 2002[21]

Breast 50–64 Gy + + + +9

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Author,year (Ref)

Tumour type Radiation therapy regimen1 Adjuvant treatments/Co-interventions

Post-operative(+)

Chemotherapy(+/−)

Additional skincare agents used

Prior Concomitant

Olsen 2001 [32] NR (gyne &brain excluded)

9–73 Gy NR NR NR −

Williams 1996[46]

Breast 45–60 Gy (1.8–2 Gy/#) (22–33#) + NR − +10

Chamomile cream vs.almond ointmentMaiche 1991[29]

Breast 50 Gy 25#; 6 MeV + NR NR NR

DressingsHazuka 1997[20] (abstract)

Breast, H & N 50–66 Gy NR NR NR NR

Management trialsTopical SteroidCreamsSchreck 2002[39]

H & N 50–72 Gy; 6 MV, 8 MeV + NR NR +11

Potera 1982[36]

H & N, ChestWall, Abdomen

H & N: 27 Gy; B: 63 Gy NR NR NR NR

Sucralfate or sucralfatederivativesDelaney 1997[12]

H & N, Breast,Other

47–53 Gy in 25–28# NR + + −12

DressingsShell 1986 [40] H & N, Chest,

Back30–69 Gy NR NR NR −13

Mak 2000 [31] Neck, chest,axilla, perineum

NR NR +14 +14 +15

# fraction(s), (+) - yes (−) - no, B breast, Gy gray(s), gyne - gynaecological, H & N head and neck, L, larynx, MeV mega-electronvolt, MV megavolt, NR not reported, P pelvis, Ref reference1Prescribed dose, fractionation, and beam energy presented unless not reported in trial2All patients in both groups also applied non-blinded emollient cream (Diprobase) over radiation area once daily3Breast cancer patients only4All groups recommended to apply baby powder three times daily to treated skin surface5If clinically necessary, patients in control group received topical treatment6Physicians treated established dermatitis of grade 2 or higher and/or allergy7Any use of anti-inflammatories, topical anaesthetics, or mucoprotectants for radiation toxicity and concomitant medication was recorded8Primary or metastatic9Patients in all groups advised to use only mild baby soap on the skin10No other prophylactic topical agents were to be applied during the study period; however, patients with pruritus and/or markederythema were to use a 1% hydrocortisone cream 2–3 times daily and patients with moist desquamation were to use Domeboro’s soak 3–4times daily; patients in all groups advised not to apply soap directly to the skin11Cream group; instructed to clean skin with water and pH-neutral wash syndents daily; powder group: instructed to wash with watertwice weekly12Cream washed off prior to radiation treatment13Moderate skin reactions cleansed by gentle washing with normal saline soaked gauze and soap; severe reactions added treatment with1/4 solution hydrogen peroxide and saline (only in hydrous lanolin group), both followed by saline rinse prior to application14Patients were stratified and divided into two subsets: i) those that received chemotherapy and radiation therapy and ii) radiationtherapy alone15Cleansed by gentle washing with 0.9% normal saline before application

Table 3 (continued)

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Amifostine

One small nonrandomized open trial compared radio-chemotherapy with or without intermittent intravenousamifostine, a thiol derivative which protects normal tissuesfrom the cytotoxic effects of radiation therapy and cisplatinchemotherapy [13]. A significant difference in favor ofamifostine was detected for maximum erythema grade anderythema sum scores for the 6-week trial duration (1.40±0.91 vs 3.40±2.10, p=0.003, respectively). Quality of life,pain, and itching outcomes were not assessed.

Topical acid cream

Two trials compared topical acid cream against a placebo[19, 27]. A significant difference in favor of hyaluronicacid (HA) cream was detected in the double-blind trial byLiguori [27] but no significant differences between treat-ment groups (ascorbic acid (ASC) vs placebo) weredetected in the smaller, intraindividual comparison byHalperin [19]. Global judgements of therapeutic efficacyand tolerability were scored (poor to excellent) in the trialby Liguori [27]. A significant difference in efficacy wasdetected by both the physician and patient in favor of HAcream (p<0.01 and p<0.05, respectively). There was nosignificant difference between groups in terms of toler-ability. In the trial by Halperin [19], data were analyzed on77% (65/84) of patients. Eighty-five percent of the 65evaluable patients showed either no preference for eitherintervention (35/65) or a preference for the placebo(20/65). Only ten patients (15%) showed a preference forASC.

Aloe vera

Three randomized trials assessed the efficacy of aloe verafor the prevention of radiation skin reactions [21, 32, 46].Two were large-blinded trials, but the radiation treatmentsvaried somewhat between the trials [21, 46]. After the posthoc observation from the blinded trial wherein patients hadless dermatitis than expected, Williams [46] also conducteda non-blinded trial comparing aloe vera gel vs no treatment.The trials detected no significant differences betweengroups in cumulative probability, prevalence, or time orduration of erythema [21, 32, 46] or severe dermatitis [46],and in one trial, dry desquamation was significantly lowerin the control group [21]. Neither of the two trials thatassessed itching detected significant differences betweengroups [21, 32], and pain was assessed in only one trial[21], with a significantly greater cumulative probability of≥Grade 2 pain reported in the aloe vera group (25 vs 17%,p=0.03). There was no significant difference betweengroups in terms of prevalence or duration of pain.

Chamomile cream vs. almond ointment

The extent of acute skin reaction, pain, and itching werereported in the only trial that assessed chamomile cream vsalmond ointment [29]. No statistically significant differ-ence in the frequency of skin reaction was detectedbetween treatment groups, although ≥Grade 2 reactionsseemed to appear later and less frequently in the chamomilecream-treated areas compared to the almond ointment-treated areas, but that difference was not significant (pvalue not reported). Patients’ experience of itching andpain were not quantitatively analyzed, but the authorsreported no difference between treatment groups.

Dressings

In a comparative study published only in abstract form, theprophylactic use of a liquid polymer adhesive skin sealant(PASS) was compared to a group of no-treatment historicalcontrol patients [20]. Nineteen out of 55 (35%) treated sitesshowed ≥Grade 2 desquamation and the PASS grouprequired fewer treatment interruptions compared to con-trols. Statistical analyses were not reported and limitedinformation on the control group was provided.

Studies on management of acute skin reaction

Topical creams

Two small trials used patients as their own controls toassess topical steroid creams for the management ofradiation skin reactions [36, 39]. No significant or relevantdifferences were reported in the degree of skin reaction [36,39], the duration and intensity of skin reactions [36], or inpatients’ scores of local warmth, tension, itch, pain, orgeneral discomfort [39]. The Potera [36] trial wascategorized under management because the study aimwas to determine whether hydrocortisone cream waseffective in reducing acute radiation dermatitis, and theapplication of the creams did not commence until 2 weeksafter the start of radiation therapy (in the preventionstudies, cream application typically began before or atinitiation of radiation therapy).

Sucralfate/sucralfate derivatives

One small randomized trial assessed sucralfate cream forthe management of moist desquamation [12]. Patients wereeligible if they had developed a measurable area of moistdesquamation [≥Grade 3 by the Radiation Therapy Oncol-ogy Group (RTOG) criteria]. There was no significantdifference in the mean time to healing or in the rate of painimprovement. Significant heterogeneity between treatment

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arms was detected at baseline: sucralfate patients wereprescribed a higher total skin dose (53.4 vs 47.2 Gy), andmore fractions (28.5 vs 25.2), had more prescribed days ofradiation remaining after randomization (11.3 vs 6.2 days)and had larger areas of moist desquamation than controlpatients. Several patients receiving sucralfate, but nocontrol patients, reported itching at the treatment site.

Dressings

Neither of the two small trials [31, 40] that compareddressings for the management of acute skin reactiondetected a significant difference in the time to healing,even after adjustment for the use of concomitant chemo-therapy, which was a stratification factor in the Mak trial(p=0.62) [31]. Pain scores were not significantly differentin the trial by Shell [40]; however, Mak [31] reported asignificant reduction in pain severity and frequency in thegentian violet group. In the latter study, mean wound sizeswere significantly smaller in the gentian violet group, andpatients receiving the hydrocolloid dressing had signifi-cantly higher ratings of dressing comfort (p=0.002) andaesthetic acceptance (p=0.007) compared to controlpatients [31].

Sensation of burning and quality of life (Table 2)

Only three trials [4, 37, 38] assessed patients’ experience ofthe sensation of burning of the skin. No significantdifferences between treatment groups were detected.

Two trials, one double-blinded [38] and the other open[16], reported on quality of life (QOL), using validatedassessment tools. Neither trial reported significant differ-ences between treatment groups. In one trial, patients withGrade 2 toxicity had significantly worse QOL (p=0.048)[16] and in the other, general QOL (as measured by the36-item short form health survey, SF-36) improved in bothgroups after the termination of radiation therapy [38].The more specific Skindex scale detected significant ornear significant differences between treatment groups onthree of the seven dimensions (p<0.05) [38], in favorof the corticosteroid (MPA) group compared with thedexpanthenol group.

Adverse events

It was often difficult to differentiate whether authors reportedtoxicities such as pain, burning, and itching as effects of thetreatment agent or effects of radiation therapy, which madecomparisons between trials problematic. Furthermore, not allthe trials reported whether other skin care practices, such aswashing or the application of other topical agents, wererestricted, which could influence effect size.

Adverse events were generally mild to moderate forthose trials that assessed topical agents [4, 8, 12, 14–16,19–21, 27–32, 35–40, 45, 46]. The most commontreatment-related toxicities were allergic reaction to thetopical agent, itching, burning, and moist desquamation.Overall, there were no significant differences in adverseevents between treatment groups for those trials evaluatingtopical agents, aside from one trial [21] that reportedsignificantly less pain in the aqueous cream groupcompared to patients in the aloe vera cream group. Allergicreaction was the most commonly reported adverse reactionin the aloe vera trials.

Toxicities were more severe where oral or intravenousagents were used [11, 13, 18, 22, 26]. Gastrointestinal upsetwas the most common adverse effect and led 19 patients towithdraw from the trial by Lievens (12 in the sucralfategroup and seven in the placebo group) [26]. One of theshortcomings of one of the trials assessing oral enzymes[11] was that it did not distinguish between radiationtherapy-induced and enzyme therapy-induced side effects,when some of the common side effects of oral enzymetherapy (i.e., gastrointestinal) are also typical side effects ofpelvic radiation therapy. No significant differences in toxicevents between treatment groups were reported [11, 18,22]. Toxicities reported by Gujral [18] included pain/bodyache, fever, weakness, vomiting, itching, hemoptysis, andswelling, which were generally mild and of short duration.The most common treatment-related toxicity in theamifostine trial [13] was grade I nausea, which occurredin seven out of 15 (47%) patients [13]. Two patients (13%)in the treatment group experienced grade II nausea.Maximum nausea scores and maximum hypotension scoreswere significantly higher in the amifostine group comparedto the control group (p=0.002 and p=0.008, respectively).Despite the significant reduction in the degree of skinreaction detected in the group receiving intravenousamifostine, the increase in adverse effects experienced bythose patients should not be overlooked.

One of the management trials [40] reported that fivepatients (24%) were eliminated from the original studypopulation due to development of significant woundcomplications (two patients in the MVP group and one inthe lanolin group developed staphylococcus infections, onepatient in the lanolin group developed folliculitis, and onepatient in the lanolin group developed a sensitizationreaction) [40]. There were no treatment-related toxicitiesreported in the remaining management trials [12, 31, 36, 39].

External review

Feedback of a draft version of the guideline was obtainedthrough a mailed survey of 264 practitioners and healthcare professionals in Ontario. One hundred elevenrespondents indicated that the report was relevant to theirclinical practice and completed the survey. The survey

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consisted of items evaluating the methods, results, andinterpretive summary used to inform the draft recommen-dations and whether the draft recommendations aboveshould be approved as a practice guideline. Writtencomments were invited.

Of those who responded, 86% felt there is a need for aclinical practice guideline on this topic. Eighty-two percentof the respondents agreed with the draft recommendation,and 69% felt the report should be approved as a practiceguideline. The main concern of the 51% of practitionerswho provided written comments was the overall lack ofscientific evidence. Reviewers were concerned that as aguideline is based on available evidence, a lack ofevidence, therefore, results in “unuseable” recommenda-tions. The suggested solution was that an SCGG opinionssection be introduced to clarify the issues until moreconcrete evidence becomes available. The SCGG reviewedpractitioners’ comments and revised the guideline. Spe-cifically, the issue surrounding the lack of evidence washighlighted throughout the guideline, using the phrase“insufficient evidence to support or refute” where appli-cable instead of “recommend”.

As part of the guidelines development cycle, the PGCCalso reviewed and approved the draft guideline document,ensuring consistency of methodology and interpretation ofdata. One key suggestion was to include a list of suggestedproducts that fall under the label “mild” shampoo, so thatthose could be recommended to patients. The SCGGconsidered that comment but decided not to suggestspecific products because of a lack of supporting evidence.Furthermore, there might be products on the market thatcould be considered “mild” that the group members are notaware of, in which case, endorsing one product overanother would introduce bias. No changes were made inresponse to feedback from the PGCC.

Discussion

Prevention of acute skin reaction

The main recommendation arising from this review of theevidence is that gentle skin and hair washing should beunrestricted in patients receiving radiation therapy.Although only two of the three trials examining washingpractices detected a benefit in the washing group [8, 37],the evidence was felt to be sufficient to supportrecommendations. In the Westbury trial [45], patientsrandomized to not washing were instructed to avoid (ratherthan restrict) washing, which could explain why a positiveeffect was not detected in that trial.

There would seem to be no barrier to using a mild soapand gentle washing during radiation therapy, and indeed,being permitted to wash during radiation therapy was feltby 78% of patients, in the trial by Campbell [8], to be veryimportant. In that trial, patients randomized to washing

were instructed that they could wet the treated skin surfacein a warm shower or by immersion in a warm bath but weretold not to soak in the bath or to rub the treated skin and toeither drip dry or pat dry with a towel. Patients who washedwith soap and water were given similar instructions andinstructed to use baby soap or mild soap (but no bubblebath, shower gel, or body lotion) [8]. Patients, in the otherpositive trial by Roy [37], were instructed to gently washwith warm water and mild soap (i.e., Dove® or Ivory®) butnot to use the shower or bath or very cold or very hot waterand to use soft patting to dry the skin. There was, however,no definition of “mild” soap provided in any of the washingtrials.

The largest randomized trial included in this review ofthe evidence compared calendula vs Biafine, and asignificant reduction in ≥Grade 2 dermatitis and in painresponse was detected in the calendula group. Nonetheless,the shortcomings of the trial should be considered. The trialwas only single-blind (physician-blinded) and 30% ofpatients found calendula difficult to apply compared toonly 5% of patients reporting difficulty in the Biafinegroup, and calendula was, therefore, not recommended.

As mentioned, the quality and quantity of studiesevaluating the use of topical and oral agents did notallow for specific recommendations in those areas. There issome evidence to suggest that the use of certain topicalsteroid creams [4, 28] and topical acid creams [27] has aradioprotective effect, but more studies are needed tosupport recommendations. There is limited evidence tosupport the use of sucralfate, Biafine cream, aloe vera,chamomile cream, or dressings for the prevention of acuteradiation skin reactions.

One nonrandomized open trial evaluated amifostine in atotal of 30 patients receiving radiochemotherapy anddetected significantly lower maximal erythema scores inthe amifostine group. However, randomized trials areneeded to confirm whether intravenous amifostine admin-istration is beneficial in preventing acute skin reactions. Adisadvantage to the use of that agent is the requirement of apermanent venous access for daily injections. The threetrials that evaluated oral enzymes detected a significantbenefit in favor of enzyme therapy. The side effectsreported in those trials, however, were more oppressivethan those reported in trials evaluating topical agents andshould be considered. Moreover, that enzyme is notcurrently available in Canada, and no further trials arecurrently underway. Overall, the benefits do not outweighthe risks in the trials evaluating the efficacy of oral andintravenous agents.

Management of acute skin reaction

The agents examined in this area were steroid creams,sucralfate cream, and various dressings. No two trialsevaluated the same treatment regimen, limiting compar-

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isons between studies. There is a lack of strong evidence onthe management of radiation therapy-related wounds suchas moist desquamation. There is a need to match the care ofmoist desquamation with the best available wound care,such as wound dressings that promote a moist woundenvironment. As none of the trials demonstrated a positiveeffect on skin reaction, recommendations on the bestmanagement of radiation skin reactions cannot be made.

Future research

In the opinion of the SCGG, agreement among researcherson outcome assessment tools for degree of skin reaction,pain, itching, and quality of life would enable bettersynthesis of the evidence. Including quality of life as anoutcome in future trials is important. Oral enzymes showedpromising results in the prevention of radiation skinreactions; however, a large double-blind randomized trialwould be necessary to confirm these results. Randomizedtrials evaluating the benefits of moisturizing cream orlotion in both the prevention and management of acute-skinreactions are strongly needed. Specifically with regards toskin reaction management, more trials aimed at assessingthe efficacy of various dressing on moist desquamation areneeded as are trials examining irradiated sites, such as theperineum and areas of skin folds, where risk factors andmanagement may differ.

Practice guideline

Prevention of acute skin reaction

1. Skin washing should not be restricted in patientsreceiving radiation therapy. Recommended washingpractices include gentle washing1 with water alone orgentle washing with mild2 soap and water.

2. Patients receiving radiation therapy to the head shouldbe advised to follow gentle washing practices withmild shampoo.

3. Limiting personal hygiene practices is not recom-mended as this may lead to psychosocial distress forthe patient.

4. Limited evidence suggests that calendula ointmentmay decrease the occurrence of ≥Grade 2 radiation

dermatitis in breast cancer patients. Its application inother types of cancer is unknown at this time.

5. There is insufficient evidence to support or refute otherspecific topical agents (i.e., corticosteroids, sucralfatecream, Biafine, ascorbic acid, aloe vera, chamomilecream, almond ointment, or polymer adhesive skinsealant) for the prevention of acute skin reaction.

6. There is insufficient evidence to support or refutespecific oral agents (i.e., enzymes, sucralfate) orintravenous agents (i.e., amifostine) for the preventionof acute skin reaction. The side effects of these agentswere more oppressive than those reported in the trialsassessing topical agents, and therefore, the benefits donot outweigh the risks.

Management of acute skin reaction

There is insufficient evidence to support or refute topicalagents such as corticosteroids, sucralfate cream, or specificdressings for the management of acute skin reaction.

Opinions of the supportive care guidelines group

1. Clinical experience suggests that initial use of a plain,non-scented, lanolin-free hydrophilic cream is helpfulfor patients experiencing radiation skin reactions. Thattype of cream attracts and traps moisture at the skinsurface to increase the skin’s moisture and maintainskin pliability. The cream should be discontinued whenskin breakdown occurs.

2. Clinical experience suggests that low dose (i.e., 1%)corticosteroid cream may be beneficial in the reductionof itching and irritation. There does appear to be aninflammatory process associated with radiation-in-duced erythema [15] that may be alleviated somewhatby corticosteroid creams. More evidence is needed tosupport firm recommendations.

3. Caution must be used to avoid the overuse ofcorticosteroid cream [23]; however, there is limitedevidence to suggest that skin thinning would pose aproblem for normal corticosteroid use during anaverage course of treatment (up to 8 weeks) [43].The practitioner must also be aware of potential patientallergies to topical corticosteroids and discontinue useif an allergic reaction occurs.

Acknowledgements The PEBC is sponsored by, but editoriallyindependent of, Cancer Care Ontario and the Ontario Ministry ofHealth and Long-Term Care.The SCGG would like to thank Ms. Karima Velji for her

contribution during the initial stages of the development of theguideline and Ms. Julie Wilson for assisting in the preparation of thismanuscript.

1 “Gentle washing” involves using lukewarm water and taking carenot to rub the skin. Showers should also be lukewarm and shouldhave low pressures.2 “Mild soap” is defined as a pH-balanced, non-scented product thatdoes not contain lanolin. There is no evidence to suggest that onetype of mild soap is preferable to another. However, in one studythat rated the irritant quality of 18 soaps, “Dove” was the only soapclassified as mild and may, therefore, be considered [17].

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