What current evidence is there to give the optimal skin care advice

to patients undergoing radical external beam megavoltage

radiotherapy?

IntroductionIntroduction

Turesson et al. (1996) demonstrated that the number of basal cells in the epidermis declines during fractionated RT due to increased cell cycle arrest and reduced mitosis. This causes a thinning of the epidermis and an inflammatory reaction and the variation in the reaction appears to be a genetic predisposition related to individual DNA repair capacity. (Chang-Claude et al., 2005; Pinar et al., 2007; Andreassen and Alsner, 2009)

Certain clinical factors can aid in the prediction of which patients are more likely to experience a significant radiation reaction. (Russell et al., 1994; Russell 2010)

Extrinsic and Intrinsic Extrinsic and Intrinsic factorsfactors52% of departments are not recording this data

Extrinsic factors Extrinsic factors Intrinsic factors Intrinsic factors

RadiotherapyDose, fractionation, site, and modality of radiotherapy.

Age

Bolus Nutrition

RadiosensitisersSome Cytotoxic agents can increase the severity of reaction e.g. Cisplatin, 5-Flurouracil, Mitomycin C.

Smoking and alcohol

Chemicals/ thermals/ mechanical irritants

Co-morbiditiese.g. diabetes

Previous damage

Trauma

Obesity

Infection

UV exposure

Systematic ReviewSystematic Review

An extensive literature review was undertaken of over 300 articles from 1980 to October 2010.

Two systematic reviews of skin care literature proved invaluable in determining the more robust evidence base. (Bolderston et al., 2006; Kedge 2009)

2014 systematic review undertaken using PICO method and SIGN to determine if, since 2010 there has been any additional evidence. Three systematic reviews also reviewed. (Butcher and Williamson, 2012; Schnur et al., 2013; Chan et al., 2014)

Contraindicated productsContraindicated products

Of significant note is the identification of certain products contraindicated for use on radiotherapy skin reactions:

Topical antibiotics, unless there is a proven infection. (Sitton, 1992; Campbell and Lane, 1996; Korinko and Yurick, 1997)

Topical steroids on broken skin due to the adverse effect on the wound healing process. (Blackmar, 1997; Rice, 1997; Jones, 1998)

Gentian Violet due to potential carcinogenic side effects. (Campbell and Lane, 1996; Rice, 1997; Boot-Vickers and Eaton, 1999)

ConsensusConsensus

There are two areas where a more general consensus on guidance is closer to being achieved.

Firstly with respect to the use of aqueous cream:This has now been reclassified in the British National Formulary (BNF) as a soap substitute and may be applicable in this usage for patients undergoing radiotherapy.However, it should not be used as a leave-on moisturiser.

Secondly with respect to the use of deodorant, where a much stronger evidence base refutes the adverse impact that deodorants were once thought to have. (Bennett, 2009; Watson et al., 2012; Wong et al., 2013)

2014 systematic review2014 systematic review

A number of studies have been undertaken investigating the use of topical steroids and Wong et al. (2013) make strong recommendations for the use of prophylactic topical steroids. In spite of this some of the published research recommends exercising a degree of caution, particularly regarding any long term implications of using steroids.

A plethora of agents is being used on the skin in a non-standardised fashion.

Overall, the evidence base is not strong enough to either support or refute the use of any particular product for topical application.

Prophylactic skin care (1)Prophylactic skin care (1)

A lack of evidence to support prophylactic use of any specific product

(Wells et al., 2004; Richardson et al., 2005; Russell, 2010; Gosselin, 2010)

2011 survey 2014 survey26 aqueous cream 17 aqueous cream 5 aloe vera base 6 E453 Diprobase® 2 Diprobase ®2 Cavilon® 2 Aquamax ®1 calendula base1 Cavilon ®

1 patient use own

49% of departments do not assess what a patient currently uses

Prophylactic skin care (2)Prophylactic skin care (2)

Evidence indicates that gentle skin and hair washing should be

unrestricted for patients and there should be:

no restriction to using a specific type of soap (Roy et al., 2001; Bolderston et al., 2006; Aistars and Vehlow, 2007;

Butcher and Williamson, 2012)

2011 42 specified the type of soap to use: ‘Simple®’, ‘Dove®’ or ‘none’ being the most common answers.

2014 31 specified the type of soap.

74% of departments report washing restrictions

Prophylactic skin care (3)Prophylactic skin care (3)

2011 9 specified the type of deodorant to use: ‘none’ or ‘Pitrok®’ being the most common answers.

2014 19 departments stated patients could use a deodorant; 23 stated they could not. “If patient insists they prefer to use something then rock salt from Holland and Barrett.”

55% departments are still saying ‘no deodorant’

Breast cancer patients who are advised not to use a deodorant often cite this as one less area of control they have in their life and they note concern regarding body odour. (Komarnicki, 2010)

ErythemaErythema

2011 survey 2014 survey49 aqueous cream 24 aqueous cream8 aloe vera base 6 E45 ®7 Diprobase® 4 Diprobase ®4 Cavilon® 4 Aquamax ®

4 aloe vera base3 hydrocortisone 1%3 BioOil ®3 hydrogel product

29 ISSUED the product15 products cited

Erythema tends to occur at 2000-4000 cGy

aqueous cream may actually comprise skin integrity (Tsang & Guy, 2010; Patel et al., 2013)

Dry desquamationDry desquamation

2011 survey 2014 survey35 aqueous cream 16 aqueous cream24 hydrocortisone 1% 5 hydrogel productdespite some contradictory 5 Diprobase ® evidence 4 hydrocortisone 1% (Sitton 1992; Bostrom et al., 2001; 4 E45 ®Sperduti et al., 2006; 3 patient’s own El Mandani et al., 2012)

33 ISSUED the product

13 products cited

Dry desquamation occurs mainly at 3000 cGy and higher

Moist desquamation Moist desquamation

2011 survey 2014 survey33 hydrogel product 13 Intrasite ®21 silicone dressing 10 Mepilex ®

i.e. Mepitel® 10 Polymem ®18 hydrocolloid base 10 hydrogel product7 lyofoam base 7 Flamazine ® 3 lanolin2 gentian violet 40 ISSUED the product1 second skin product 22 products cited

Moist desquamation tends to occurs at 4000 cGy and higher

Recommendations (1)Recommendations (1)

Pre-treatment The various factors that influence how people react to

radiotherapy need to be considered. (Turesson, 1996; Porock et al., 1998; Porock and Kristjanson, 1999; Richardson et al., 2005; Barnett et al., 2011; McQuestion, 2011)

Before radiotherapy begins, it is essential that a baseline assessment of the patient’s current skin condition and care is documented, including what skin products are being used currently. Assessments and review of the skin should continue for all patients on a regular basis throughout treatment. (Richardson et al., 2005; Fisher et al., 2006; NHS Scotland, 2010)

Education and health promotion strategies and interventions given to patients pre-treatment such as nutritional advice and smoking cessation would be beneficial and are advised. (Wells et al., 2004; Wan et al., 2012; Sharp et al., 2013)

Recommendations (2)Recommendations (2)

Wash the skin gently with soap and water and gently pat dry. (Aistars, 2006; Bolderston et al., 2006; Aistars and Vehlow, 2007; Butcher and Williamson, 2012)

Use aqueous cream instead of soap if wished but it is NOT recommended as a leave-on moisturiser. (www.evidence.nhs.uk/formulary/bnf)

Use a moisturiser that is sodium lauryl sulphate free. (Tsang and Guy, 2013; Patel et al., 2013)

Continue to use normal deodorant (unless this irritates the skin), but discontinue if the skin is broken. (Bennett, 2009; Butcher and Williamson, 2012; Watson et al., 2012; Wong et al., 2013)

Things to consider as an Things to consider as an issuer issuer

With a wide variety of products currently available there are bound to be variations in product utilisation and availability; therefore, careful assessment and justification is paramount.

?? What are the variation of ingredients in products that use the same generic name e.g. aloe vera, aqueous cream?

?? Is a product actually worth the cost?

? ? How available and reliable is the supplier?

?? How often does a product need to be applied?

?? How easily is the product applied?

On broken skin Use appropriate dressing/product on broken skin to

reduce further trauma and infection. Suitable products would be non-adhesive, silicone low adhesion, non or low paraffin/petroleum jelly based.

NOT use Gentian Violet. (Campbell and Lane, 1996; Rice, 1997; Boot-Vickers and Eaton, 1999)

Recommendations (3)Recommendations (3)

Future research needed (1)Future research needed (1)

New high quality trials are urgently required; enabling a more consistent approach for patients receiving radiotherapy and to inform guidelines.

There is a need for further research of new products before they are introduced on an ad-hoc basis, without evidence, into radiotherapy skin care regimens.

Future research should include designs that allow assessor blinding and comparators should include ‘current best evidence practice' or 'no intervention'.

Number of studiesNumber of studies

2011 survey Only 1 (n= 49) department was conducting a RCT into the clinical

effectiveness of a topical agent for erythema.  There were no assessments into the cost effectiveness for erythema.

Only 3 (n=46=6%) departments were conducting RCTs into the clinical effectiveness of a topical agent for moist desquamation. There was one on-going assessment into the cost effectiveness of a product.

2014 survey Only 4 (n=42=9%) departments stated they were conducting or had

conducted any trials or evaluation into efficacy of any skin care products at any stage of skin reaction and only 4 (n=42=9%) had assessed cost effectiveness. “would like to be involved with RCT's but find it difficult to sustain with clinical workload and other responsibilities” and “we would like to undertake this sort of analysis but time and resources prohibit this”.

Future research needed (2)Future research needed (2)

Assessment and quantification of the extent of radiation induced skin reactions is needed as currently it is unknown how many patients are affected and to what level. Departments need to audit radiation induced skin reactions locally to monitor proportions of patients that develop different RTOG graded reactions across different treatment sites:

1. To increase the quality of information that can be given to patients;

2. To allow departments to monitor their own practice and compare across centres.

The extent of the problem?The extent of the problem?

Future research needed (3)Future research needed (3)

Evaluation into wet versus dry shaving and perfume and make-up use is needed.

Evaluation of treatment aftercare requires review to ensure local continuity and consistency of care across the patient pathway.

Further investigations into the skin care reactions: superficial, orthovoltage, and proton beam radiotherapy are required.

Patient preferences and compliance.

The current positionThe current position

Overall, the evidence base is not strong enough to either support or refute the use of any particular product for topical application.

Currently, some of the skin care provided may not actually alleviate the problem and indeed may even compound the effect.

Are we actually providing skin care advice to patients based on traditional knowledge and a paternalistic approach to healthcare? (Harris, 2002)

The patient perspectiveThe patient perspective

Health is:" ... a state of complete physical, psychological, and social well-

being, and not merely the absence of disease or infirmity.“ WHO (1978)

“ We are people, not just bodies.”Patient 7: Harris (1995)

As Gosselin, et al. (2010) noted: “patients prefer to take action rather than do nothing”

ConclusionConclusion

The extent of skin conditions is largely unknown. Although the majority of skin reactions subside after a few weeks, some can be prolonged and affect a patient’s quality of life.

It may not be possible to stop or even reduce the rates of skin reaction from occurring, but there may be comfort and psychosocial benefits that skin care products provide.

Working partyWorking party

  

Dr Rachel Harris, Professional and Education Manager, SCoRCharlotte Beardmore, Director of Professional Policy, SCoRAmanda Bolderston, Provincial Professional Practice & Academic Leader, BCC Agency,

CanadaGemma Burke, Senior Lecturer and Professional Development Facilitator, SHUSarah James, Professional Officer for Radiotherapy, SCoRDr Heidi Probst, Reader in Radiotherapy, SHUClaire Bennett, Programme Leader for Radiotherapy and Oncology programme, UWESamantha Bostock, Superintendent Radiographer, Gloucestershire Oncology CentreCarole Downs, Breast Cancer Specialist Radiographer, Northern Centre for Cancer Care Professor Sara Faithfull, Strategic Lead for Innovation and Enterprise, University of

Surrey Sonja Hoy, Nurse Specialist for Head & Neck, The Royal Marsden NHS Foundation TrustAudrey Scott, Macmillan Head and Neck CNS, Mount Vernon Cancer CentreDr Diana Tait, Consultant Clinical Oncologist, The Royal Marsden NHS Foundation TrustEllen Trueman, Senior Radiotherapy Sister, St James's Institute of OncologyProfessor Mary Wells, Professor of Cancer Nursing Research & Practice, University of

Stirling