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Management of erythema and skin preservation; advice for patients receiving radical radiotherapy to the breast: a systematic literature review

Published online by Cambridge University Press:  24 February 2011

K. Butcher*
Affiliation:
Therapy Radiographer, The Beacon Centre, Musgrove Park Hospital, Taunton, UK
K. Williamson
Affiliation:
Lecturer/Course Leader: BSc (Hons) Radiotherapy & Oncology, Cardiff University, UK
*
Correspondence to: Kathryn Butcher, The Beacon Centre, Musgrove Park Hospital, Taunton, Somerset TA1 5DA, UK. E-mail: kathryn.butcher@tst.nhs.uk
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Abstract

Objective: To systematically review and critically appraise all evidence on skin care advice and products tailored for patients receiving radical radiotherapy for breast cancer and to determine an evidence-based conclusion regarding the most effective products.

Data Resources and Review Methods: Major healthcare databases were searched with additional efforts made to hand-search current journals. All relevant literature fulfilling the inclusion and exclusion criteria was subjected to quality assurance checks. Those that passed underwent a more rigorous appraisal and were included in the review.

Results: Ten studies were identified as fulfilling the review criteria with regards to aims and quality. All were randomised controlled trials; three were double-blinded, three were single-blinded, the remaining were not blinded. Two addressed washing regimes, two addressed deodorant use, whilst the six remaining studies investigated creams, gels or dressings.

Conclusions: The results suggest that there is a place for creams in the management and delay of radiation-induced skin toxicities; however, research fails to highlight one product which has a demonstrable benefit over others whilst still being cost effective and free from adverse effects. Patients should not be discouraged from washing with water or mild soaps and results suggest that the restriction of aluminium-free deodorant during treatment is unnecessary; however, more research in this area is needed with larger sample sizes.

Type
Literature Review
Copyright
Copyright © Cambridge University Press 2012

INTRODUCTION

Erythema, dry desquamation and moist desquamation are recognised skin reactions that can occur as a direct consequence of radiotherapy. Despite advancements in skin sparing techniques, skin reactions are still the most common side effect of radiotherapy, with as many as 95% of patients experiencing some degree of skin reaction.Reference Porock and Kristjanson1,Reference Richardson, Smith, McIntyre, Thomas and Pilkington2 Erythema is defined as redness of the skin due to dilation of dermal blood vessels.Reference Macpherson3 The Acute Radiation Morbidity Scoring Criteria, established by the Radiation Therapy and Oncology Group (RTOG) in 1981, is still the foremost method for assessing and reporting radiation skin reactions (Table 1).Reference Cox, Stetz and Pajak4

Table 1. A table outlining the RTOG Acute Radiation Morbidity Scoring Criteria as described by Cox et al (1995). Reference Cox, Stetz and Pajak4

Radiotherapy-induced erythema is caused by radiation damaging the mitotic abilities of cells within the basal layer. This weakens the integrity of the skin as cells are unable to replicate sufficiently to replace damaged tissue which ultimately results in breakdown of the skin. Skin reactions typically become visible after the skin has received doses of 20 to 25 Gray (Gy),Reference Wells, Macbride, Faithfull and Wells5 usually within the second or third week of a course of radical radiotherapy, when the patient is receiving a maximum daily dose of 2 Gy. A peak reaction is reached approximately 1 week after treatment completion.Reference Richardson, Smith, McIntyre, Thomas and Pilkington2

The severity of skin reactions are dependent on factors including volume of tissue treated, total daily dose, fractionation and individual factors such as the patient’s smoking habits and whether they are diabetic or obese.Reference Richardson, Smith, McIntyre, Thomas and Pilkington2,Reference Fisher, Scott, Stevens, Marconi, Champion, Freedman, Asrari, Pilepich, Gagnon and Wong6 The impact of a skin reaction on a patient’s quality of life is often underestimated by healthcare professionals. Moist desquamation can occur in the infra-mammary fold following breast irradiation, often having a significant impact on the physical and psychological well-being of patients. The reaction can be painful, unsightly and may prevent patients from wearing a bra. The Society and College of Radiographers (SCoR) guidelines7 for the management of skin reactions advises against the use of deodorants and recommends that only mild soaps are used during treatment. Such restraints can often lead to feelings of self-consciousness associated with body odour.Reference Wells, Macbride, Faithfull and Wells5

Standard advice given to patients encourages the daily application of ointments such as Aqueous cream to moisturise the skin and delay the onset of erythema.7 During treatment patients are encouraged to wash their skin using tepid water and mild soap, rinsing thoroughly and patting the area dry with a soft clean towel. No adhesive tape or perfumed products should be used in the treatment area peri- or post-radiotherapy. One percent Hydrocortisone cream can be applied sparingly to pruritic areas.Reference Burnet and Harmer8

SCoR guidelines are intended to prevent exacerbation of the inevitable skin toxicity of radiotherapy.Reference Porock and Kristjanson1 Despite guidelines being in place, there appears to be a wide variation in skin care advice given to patients in radiotherapy centres nationwide regarding the type of creams and dressings which should be used to manage skin reactions. There also appears to be a variation in the washing advice given to patients during treatment. The aim of this study is to systematically review the evidence on skin care products, washing regimes and advice tailored for patients receiving radical radiotherapy for breast cancer, and to determine an evidence-based conclusion regarding the most effective products to manage skin reactions for these patients.

METHOD

The method used was structured around a 5-step framework described by Khan et al.Reference Khan, Kunz, Kleijnen and Antes9

Framing question

This details the necessary components of research questions. It includes a population, (a group of participants and their clinical problem), the intervention (the main action being considered), the outcome, clinical changes in health state and the study design. This is known as the PICO framework.Reference Craig, Craig and Smyth10 It can be utilised for both the research question and as a search strategy for literature selection.

Identifying relevant literature

A comprehensive search was carried out using major medical databases including CINAHL, MEDLINE, AMED, CENTRAL (Cochrane Central Register of Controlled Trials), DARE (Database of Abstracts of Reviews of Effects) and the British Nursing Index. The search period began in August 2009 and continued throughout the writing process to ensure any new relevant studies were included. The final search was undertaken in September 2010. Reference lists of relevant articles were reviewed to identify further studies. Hand searching of key journals was carried out to help identify up-to-date applicable articles. Key journals included Clinical Oncology, Radiotherapy and Oncology, European Journal of Cancer Care, International Journal of Oncology, Biology, Physics and the Journal of Radiotherapy in Practice. All literature searches were carried out by the two authors. The basic search terms used are included in Table 2.

Table 2. The basic search terms utilised, including truncation used during literature searching

The search method and the search terms used were based on the results of a preliminary search; additional search terms were included to ensure comprehensiveness.

Only articles published in English were included due to translation of non-English language articles not being feasible (Figure 1).

Figure 1. Refining process for the literature search to aid identification of only relevant literature, it includes the number of articles acquired (n) and excluded with each step (xn) (adapted from Khan et al. pp 229)

The inclusion and exclusion criteria were integral to the refining process. Amendments were made during the search as the original criteria was found to be too restricting and led to a shortfall in literature within the research field of interest excluding articles which would have strengthened the conclusion (Table 3).

Table 3. The final inclusion and exclusion criteria utilised

Assessing literature quality

The literature acquired was chosen using a quality checklist, ensuring the literature used was reliable and robust enough to support the conclusion. Only one reviewer assessed the quality of each article; this decision was based on financial constraints and the original format of the article, as a university dissertation piece. The reviewer was not blinded to the journals used or the authors; however, no journal or author was excluded from the search and no preferences or prejudice shown in either area (Table 4).

Table 4. The Quality Assessment Checklist utilised

Each area within the table above was designed to address each of the known biases that commonly occur within systematic reviews including selection, performance, measurement and attrition bias. Any other points of interest found within the articles were noted to help strengthen the review; similarly, any other areas of weakness within the articles were noted.

Summarising evidence

The aim was to display the characteristics of the literature chosen, grouping it into relevant categories, thus allowing trends to be seen and the findings tabulated.

Interpreting findings

The validity of the main findings were considered. The quality of the studies and any bias observed was analysed. Consideration was given to how this review could be applied to clinical practice; this being the review objective, to clarify and aid the procedure within clinical practice with regard to skin care advice given to patients with breast cancer (Table 5).

Table 5. A summary of the research studies reviewed

n = number of participants

DISCUSSION

An initial literature search provided 68 research articles; however closer analysis highlighted a number of methodological limitations which reduced comparability and resulted in 43 articles not being suitable for inclusion. Twenty-five potentially useful articles were identified. Common limitations found included studies failing to set substantive inclusion and exclusion criteria, with some studies failing to report either entirely. Methods of randomisations, blinding and recruitment were also often reported in insufficient depth. Many studies did not provide reasons for non-attendance at follow-ups whilst some of the literature appeared to lack data and justification for chosen study methodologies. Consequently, of the 25 articles only 10 articles were included in the final review; the 15 that were rejected were done so on the basis of methodological limitations. All the studies chosen fulfilled the basic requirements of the quality assessment checklist. Small but acceptable limitations were evident in six studies. These limitations included unclear skin assessment methodology, justification of patient allocation and scope for potential bias. Blinding of patients and skin assessors was varied amongst the studies. Four studies were not blinded at all,Reference Wells, Macmillan, Raab, MacBride, Bell, MacKinnon, MacDougall, Samuel and Munro12,Reference Szumacher, Wighton, Franssen, Chow, Tsao, Ackerman, Andersson, Kim, Wojcicka, Ung, Sixel and Hayter15,Reference Campbell and Illingworth17,Reference Gee, Moffitt, Churn and Errington27 this was justified in three of the studies by the interventions being investigated, for example, it was not possible to blind patients from their intervention when they were either using deodorant or not or washing or not. Three studies were single-blindedReference Pommier, Gomez, Sunyach, D'Hombres, Carrie and Montbarbon14,Reference Roy, Fortin and Larochelle18,Reference Théberge, Harel and Dagnault20 and three were double-blindedReference Heggie, Bryant, Tripcony, Keller, Rose, Glendenning and Heath11,Reference Boström, Lindham, Swartling, Berne and Bergh13,Reference Schmuth, Wimmer, Hofer, Sztankay, Weinlich, Linder, Elias, Fritsch and Fritsch16. Organoleptic properties of some ointments and dressings meant neither the patients nor the skin assessor could be blinded. It was felt that some studies could have successfully blinded their skin assessors however they failed to, which could have led to a degree of bias. These studies were still included in the review due to their high standard of quality elsewhere, they helped strengthen the conclusion; however, their potential for bias was fully acknowledged. It is recommended that future research should pay careful attention to their blinding techniques to ensure their results are more reliable.

A number of alternative skin assessment scales have been developed in an attempt to compensate for the simplicity of the RTOG scale.Reference Wells, Macbride, Faithfull and Wells5 Five of the studies reviewed used the RTOG scale to assess skinReference Wells, Macmillan, Raab, MacBride, Bell, MacKinnon, MacDougall, Samuel and Munro12,Reference Pommier, Gomez, Sunyach, D'Hombres, Carrie and Montbarbon14,Reference Campbell and Illingworth17,Reference Roy, Fortin and Larochelle18,Reference Théberge, Harel and Dagnault20 with two of these adapting the original scale to overcome simplicity and provide more detailed assessmentReference Wells, Macmillan, Raab, MacBride, Bell, MacKinnon, MacDougall, Samuel and Munro12,Reference Campbell and Illingworth17. Both provided detailed descriptions of the changes made. Five studies did not utilise the RTOG scale,Reference Heggie, Bryant, Tripcony, Keller, Rose, Glendenning and Heath11,Reference Boström, Lindham, Swartling, Berne and Bergh13,Reference Szumacher, Wighton, Franssen, Chow, Tsao, Ackerman, Andersson, Kim, Wojcicka, Ung, Sixel and Hayter15,Reference Campbell and Illingworth17,Reference Gee, Moffitt, Churn and Errington27 instead they used alternative tools including skin assessments scales unique to their nation, reflectance spectrophotometry and measurements of transepidermal water loss. These four studies all identified the scale system and provided details with varying rigour.

Acknowledgment is given to the five studies which used quality of life assessment questionnaires. These give insight into how skin reactions and skin management techniques affect a patient’s quality of life. The intention of these studies and this review was to discover a best care technique for managing radiation-induced skin reactions thus improving a patient’s quality of life; it seems justifiable therefore to ask patients their opinions of these techniques. If patients are unable to tolerate the skin management technique despite improvement in skin reactions, the level of compliance would be poor thus failing to benefit the patient and possibly making promotion of this technique in a department futile.

One of the studies investigated skin reactions in multiple treatment areas including the breast. Its inclusion within this review was based on the quality of the study. It clearly outlined the number of patients with breast cancer included within the study and outlined their radiotherapy treatment. Further, their results were differentiated from the others. This particular study fulfilled all the desired quality assurance criteria. It was felt that it was inappropriate to reject a well-written piece of literature on the basis that it also included other radiotherapy treatments aimed at treating other forms of cancer besides breast cancer.

The SCoR guidelines recommend the use of Aqueous cream during treatment to moisturise the skin and delay the onset of erythema.7 However, alternative research carried out suggests Aqueous cream can be counterproductive for numerous patients. Cork et al.Reference Cork, Timmins and Holden19 found that 56% of episodes of exposure to Aqueous cream were associated with an immediate cutaneous reaction in children using the cream for management of atopic eczema. Interestingly, they noted patients reporting reactions to Aqueous cream obtained in one part of the United Kingdom and not another. One explanation might be that Aqueous cream is provided by a number of manufacturers who are permitted to use different preservatives. Aqueous cream was originally a wash product rather than a “leave on” emollient. Ingredients such as antiseptics and surfactants are important and safe constituents of wash products because of their transient contact with the skin.Reference Cork, Timmins and Holden19 This review encountered one incidence of an adverse reaction to Aqueous cream, whilst reactions were also seen with other products. The studies reviewed reported 7 incidences of adverse reactions to emollients prescribed and 3 incidences of adverse reactions to corticosteroid creams. Where departments follow SCoR guidelines and use Aqueous cream, it should be recommended that practitioners be made aware of the risks of adverse reactions and how to identify them. Future research could focus on the preservatives contained in Aqueous cream nationally to determine how much variation there is and how this impacts on skin care and skin reactions.

Both studies investigating washing regimes concluded that washing was beneficial to patients and should not be discouraged; there was no reported difference between washing with or without mild soap in terms of acute skin toxicity. Washing with soap appeared to provide psychological relief to many patients. This supported the recommendation by the SCoR that patients should be allowed to use mild soaps throughout treatment. The literature search highlighted a lack of studies within this area of skin care.

Another area of skin care found to cause psychological distress is the restricted use of deodorant.Reference Théberge, Harel and Dagnault20 This area of skin care is also under-researched and would benefit from further investigation. At present a literature search identified only five studies focussing on this area of skin care.Reference Théberge, Harel and Dagnault20–Reference Graham and Graham22,Reference Bennett26,Reference Gee, Moffitt, Churn and Errington27 Only two were utilised in this review.Reference Théberge, Harel and Dagnault20,Reference Gee, Moffitt, Churn and Errington27 One study was rejected because the study design was a laboratory-based study, this could not have been compared to any other study and it did not place enough emphasis on patient judgement. The other rejected study had a number of methodological flaws including insufficient data regarding radiotherapy techniques used, a lack of statistical support and detail of inclusion criteria. The final study was a literature review and survey. The survey, which provided important feedback from patients, however, was not comparative to any other study. The literature review reported the same number of articles in this area as was found with this review. All five studies advocate the use of deodorant safely throughout radiotherapy treatment despite most radiotherapy departments advising patients against it.

Four studies investigated the use of creams or gels containing anti-inflammatory properties compared with emollient creams. They indicated a slight benefit in terms of acute skin toxicity within the anti-inflammatory groups. Products containing anti-inflammatory properties included Calendula officinalis, Aloe vera and corticosteroid creams such as Mometasone Furote and Methylprednisolone Aceponate.

The use of corticosteroid creams is not routinely recommended due to the side effects associated with their use. They can cause thinning of the skin, increasing the risk of moist desquamation and the introduction and spread of bacterial infections. Patients should be advised on how to correctly apply the cream and be monitored, assessing for signs of bacterial infection.23

Five studies investigated the use of emollient creams. Upon analysis, all emollients appeared to have similar results with no considerable difference between products. This conclusion correlates with similar reviews carried in the last decade.Reference Richardson, Smith, McIntyre, Thomas and Pilkington2,Reference Glean, Edwards and Faithfull24,Reference Naylor and Mallett25

The choice of skin care products used within departments is influenced by many factors. One study highlighted the significance of cost. According to the British National Formulary (BNF)23 100 g of Aqueous cream costs £1.36 whilst corticosteroid creams are as expensive as £12.82 for 100 g. There is also a noticeable difference in price between emollients. Other factors motivating departmental choice include organoleptic qualities of the products. Three studies identified patient preference influenced by the smell, texture and colour of creams or gels.

CONCLUSION

Of the 10 skin care ointments investigated within the 10 research articles, no one product appeared to have an overall benefit over others. Although patients using corticosteroid creams had a slight increased benefit in terms of erythema, its use is not routinely encouraged due to side effects.

Evidence suggests that patients should not be discouraged from washing and mild soaps should be permitted. Similarly, the use of non-metallic deodorants does not seem to have a detrimental effect on patient’s skin reactions; also, patient feedback suggests that the restriction of deodorant use can psychologically harm some patients.

Future research could be strengthened by developing universal methods of skin assessment and ensuring that wherever possible participants and assessors are blinded to the interventions being used.

Radiotherapy departments should be encouraged to follow evidence-based guidelines with regard to support and management of skin reactions rather than provide advice based on tradition and cost.

Recommendations for future areas of research include variations in Aqueous cream ingredients and more extensive research into the use of deodorants throughout radiotherapy for breast cancer.

Acknowledgements

This work is attributed to Cardiff University, School of Healthcare Studies, Ty Dewi Sant, Heath Park, Cardiff, CF14 4XN

References

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Figure 0

Table 1. A table outlining the RTOG Acute Radiation Morbidity Scoring Criteria as described by Cox et al (1995).4

Figure 1

Table 2. The basic search terms utilised, including truncation used during literature searching

Figure 2

Figure 1. Refining process for the literature search to aid identification of only relevant literature, it includes the number of articles acquired (n) and excluded with each step (xn) (adapted from Khan et al. pp 229)

Figure 3

Table 3. The final inclusion and exclusion criteria utilised

Figure 4

Table 4. The Quality Assessment Checklist utilised

Figure 5

Table 5. A summary of the research studies reviewed