Steroids - Topical

Steroids - Topical

PEP Topic 
Radiodermatitis
Description 

Steroids are a type of compound that contain a characteristic chemical structure. Steroid drugs have anti-inflammatory activity. Topical steroids have been examined for effectiveness in the management of skin reactions such as radiodermatitis. Evidence suggests that topical steroids can reduce itching.

Effectiveness Not Established

Research Evidence Summaries

Boström, A., Lindman, H., Swartling, C., Berne, B., & Bergh, J. (2001). Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: Results from a double-blind, randomized study. Radiotherapy and Oncology, 59, 257–265.

doi: 10.1016/S0167-8140(01)00327-9
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Study Purpose:

To determine if use of mometasone furoate (MMF), a corticosteroid cream could reduce intensity of erythema in acute radiation dermatitis

Intervention Characteristics/Basic Study Process:

Patients were randomized to receive tubes of either MMF cream 0.1%  or an emollient cream as a placebo control. Patients were instructed to apply the cream on the irradiated area twice a week up to 24 Gy and then once daily for the rest of treatment and three weeks after completion of radiation therapy. All patients in both study groups also applied the emollient cream over the radiated area once daily throughout the entire study period.

Sample Characteristics:

  • The study sample (N = 50) was comprised of female patients with breast cancer who had undergone breast-conserving surgery.
  • Mean age was 58 years for the MMF group and 60 years for the control group.
  • All had a World Health Organization performance status of 0.
  • A 5 MV photon beam was delivered in 2 Gy fractions for a total dose of 54 Gy.

Setting:

The study took place in Uppsala, Sweden.

 

Study Design:

The study used a randomized double-blind controlled design.

Measurement Instruments/Methods:

  • Skin reaction was measured with a seven-point grading scale, from 0 (no reaction) to 6 (moist desquamation) evaluated in five defined skin regions at each visit. Maximum scores were used in analysis.
  • Patients’ subjective experiences of itching, burning, and pain were measured using a visual analogue scale.
  • The Mann Whitney U test was used for all statistical comparisons.
  • A reflectance spectrophotometer was used to rate erythema. The device emits various light colors corresponding to absorption peaks of hemoglobin and melanin.
  • The intensity of emitted light as measured by a photo detector was used to provide a patient erythema index and a patient melanin index. These indexes were calculated as the mean of three assessments in each of five skin regions identified for each patient.

Results:

  • The two-photon excitation was lower in the MMF group (p = 0.033)
  • The maximal skin reaction grade was lower in the MMF treated group (p = 0.011).
  • Six patients in the control group required further topical treatment because of severe subjective symptoms. Three patients in the MMF group needed further treatment of severe moist desquamation in the axilla.
  • Patients in the MMF group reported less itching and burning, but the differences were not statistically significant.

Conclusions:

MMF patients showed less pronounced erythema, less itching and less burning than emollient group. MMF may provide a benefit.

Limitations:

  • The study had a small sample size, with less than 100 participants.
  • Reliability of the seven-point scale was not stated, and it was not clear who was making observations.
  • There was no log for application of the creams, so compliance with the planned regimen was not clear. The study did show that two patients did forget to apply the MMF during the treatment period.
  • The study did not report if other skin regimens, such as washing, were allowed.
  • Both groups applied the control emollient cream, so it is unclear what effect this had on skin reactions

Miller, R.C., Schwartz, D.J., Sloan, J.A., Griffin, P.C., Deming, R.L., Anders, J.C., . . . Martenson, J.A. (2011). Mometasone furoate effect on acute skin toxicity in breast cancer patients receiving radiotherapy: A phase III double-blind, randomized trial from the North Central Cancer Treatment Group N06C4. International Journal of Radiation Oncology, Biology, Physics, 79(5), 1460–1466.

doi: 10.1016/j.ijrobp.2010.01.031
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Study Purpose:

To evaluate the effect of 0.1% mometasone furoate on a acute skin-related toxicity in patients undergoing breast or chest-wall radiotherapy

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to either 0.1% mometasone furoate cream or an identical-looking placebo cream. Patients were to apply toe cream once daily to the area under treatment not less than four hours before or after radiation therapy. Creams were used throughout the radiation therapy course. No other topical agents were to be used. If the primary physician initiated a medication other than the study agent, the study medication was discontinued and evaluations continued according to the study protocol. Patients were evaluated at baseline and weekly by treatment providers.

Sample Characteristics:

  • The study sample (N = 166) was comprised of patients with breast cancer.
  • Other sample characteristics were not clearly reported.
     

Setting:

The study took place at the May Clinic in Rochester, NY.

Study Design:

The study used a double-blind placebo-controlled randomized clinical trial design.

Measurement Instruments/Methods:

  • The National Cancer Institute's Common Termonology Criteria for Adverse Events (version 3.0) was used.
  • Patient-reported outcomes were measured using the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary (rated multiple skin toxicity signs and symptoms on a 0–10 scale), and a quality-of-life self-assessment.
     

Results:

There was no significant difference between groups in the mean grade of provider-assessed radiation dermatitis. The Skindex-16 showed no statistically significant difference between groups. In the Symptom Experience Diary, patients in the mometasome arm reported less burning, itching, and redness (p < 0.02). There was no difference between groups in quality of life.

Conclusions:

Topical mometasone furoate was associated with less burning, itching, and redness but did not show any significant effect on overall radiation-induced skin toxicity.

Limitations:

  • No demographic data were reported. 
  • It is not stated if any patients were also receiving chemotherapy or whether any patients received other topical agents as allowed. 
  • The only explanation provided for the 10% dropout rate was discontinuation.

Nursing Implications:

Findings suggest that topical corticosteroid use or mometasone does not significantly reduce the severity of radiodermatitis but may reduce patient symptoms of burning, itching, and redness. Though topical steroids may not prevent dermatitis, their use may help patients be more comfortable during radiation treatment.

Omidvari, S., Saboori, H., Mohammadianpanah, M., Mosalaei, A., Ahmadloo, N., Mosleh-Shirazi, M.A., . . . Namaz, S. (2007). Topical betamethasone for prevention of radiation dermatitis. Indian Journal of Dermatology, Venereology and Leprology, 73, 209–214.

doi: 10.4103/0378-6323.32755
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Study Purpose:

To investigate whether the prophylactic use of topical betamethasone 0.1% can prevent acute radiation dermatitis

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to one of three groups: betamethasone, petrolatum, or no treatment. The treatment delivery protocol was the same for all groups. Education on the amount of skincare product to use was consistent.

Sample Characteristics:

  • The study sample (N = 51) was comprised of female patients with breast cancer (stage I or II).
  • Age of the sample ranged from 34–66 years.
  • Patients did not undergo concurrent chemotherapy or systemic corticosteroids.
  • The total radiation dose was 50 Gy to the chest wall, with patients receiving a single 2 Gy per day for five days a week.
  • A cobalt-60 unit was used, which does not have the same skin-sparing abilities of the 3-D conformal or intensity-modulated radiation therapy.

Study Design:

The study used a randomized double-blind controlled trial design.

Measurement Instruments/Methods:

  • Patients were assessed using the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria for acute radiation dermatitis.
  • Statistical analysis was done using non-parametrical tests (Kruskal-Wallis test and Friedman test).

Results:

By the third week (30 Gy), 26.3% of the betamethasone group had grade 1 skin toxicity compared to 64.7% and 66.7% of the petroleum and control groups, respectively (p = 0.027). By the seventh week, 15.8% of the betamethasone patients had grade I skin toxicity, 6.7% of the control group had grade I, and 100% of the petroleum group had grade II or higher.

Conclusions:

Acute radiation dermatitis increased over time for all groups. The betamethasone group had lower prevalence at one time point; however, at the end of treatment, acute radiation dermatitis was lower in the untreated controls.

Limitations:

  • Skin assessment did not include the inframammary fold.
  • No statement if a patient missed a treatment.
  • Patient perceptions, such as pain or itching, were not addressed.
  • Though the study stated the aim was to prevent acute radiation dermatitis, more than 90% of the sample had grade 2 or higher acute radiation dermatitis at the beginning of the study.
  • The study had no blinding and a small sample size, with less than 100 participants.

Shaw, S.Z., Nien, H.H., Wu, C.J., Lui, L.T., Su, J.F., & Lang, C.H. (2013). 3M Cavilon No-Sting Barrier Film or topical corticosteroid (mometasone furoate) for protection against radiation dermatitis: A clinical trial. Journal of the Formosan Medical Association.

doi: 10.1016/j.jfma.2013.04.003
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Study Purpose:

To investigate the effect of 3M™ Cavilon™ No-Sting Barrier Film and topical corticosteroids on irradiated skin

Intervention Characteristics/Basic Study Process:

Thirty-nine post-operative patients with breast cancer were assigned to the three intervention groups using simple randomization. The three treatment groups included 3M barrier film versus no treatment [n = 13], Elomet® (mometasone furoate [corticosteroid] cream) versus no treatment [n = 9], and Elomet versus 3M barrier film [n = 17]. Each participant’s treatment field was divided in half so that she received both radiodermatitis treatments assigned to the group. Elomet and 3M film barrier were applied every other day, excluding weekends, by the same staff, and the reactions were observed. For patients with more advanced disease, chest wall recurrence, or lymph node involvement, those areas also were irradiated. The skin reactions in the neck and supraclavicular areas were not included in the study. The primary end points were time to onset of grade 1 pruritus, a pain score of 3, and presence of grade 2 dermatitis. The secondary end points were grade 3 radiodermatitis and pain scores by each treatment.

Sample Characteristics:

  • N = 39  
  • AGE = 30–76 years
  • MEAN AGE = 51 years
  • MALES: 0%, FEMALES: 39%
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Chest wall, remaining breast after conservative surgery, treated skin, untreated skin, post-operative

Setting:

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Taiwan

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

Open-label clinical trial of barrier film or corticosteroid cream, versus no treatment to prevent/reduce grade 1 pruritus, grade 2–3 radiodermatitis, and pain score of 3.

Measurement Instruments/Methods:

  • Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 for dermatitis associated with radiation and for pruritus
  • A pain score was collected.
  • SPSS software version 10 was used to analyze the data.

Results:

The only statistically significant result in this study was that Elomet significantly delayed the onset of grade 2 dermatitis as compared to 3M No-Sting Barrier Film. Grade 2 dermatitis: Elomet (53.4 days on treatment) versus 3M No-Sting Barrier Film (44.5 days on treatment), p = 0.002; 3M No-Sting Barrier Film (44.2 days on treatment) versus no treatment (46.6 days on treatment), p = 0.196; and Elomet  (52 days on treatment) versus no treatment (43 days on treatment), p = 0.092
 
Participants who received 3M No-Sting Barrier Film experienced a non-significant delay in grade 1 pruritus as compared to Elomet. Grade 1 pruritus: 3M No-Sting Barrier Film (32.4 days on treatment) versus Elomet (28.4 days on treatment), p = 0.072; 3M No-Sting Barrier Film (32.5 days on treatment) versus no treatment (29.4 days on treatment), p = 0.079; and Elomet  (26.4 days on treatment) versus no treatment (26.8 days on treatment), p = 0.413
 
There was no significant difference in the pain score of 3 in any arm.
 
Skin treated with Elomet had the lowest incidence of grade 3 dermatitis, but not at a significant level. Grade 3 dermatitis incidence: 3M No-Sting Barrier Film (33%), Elomet (15%), and no treatment (23%), p  = 0.289

Conclusions:

The authors recommend using the barrier film starting at the commencement of treatment to reduce friction and irritation, particularly in skin folds and the axilla. However, study findings here do not show an effect on development of radiodermatitis. Once pain and hyperemia occur, the barrier film is discontinued and corticosteroid cream started. The effectiveness of corticosteroid on prevention of radiodermatitis should be investigated further under a lager randomized study.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation:  The researchers said they used “simple randomization” to assign the participants to the three treatment groups. They did not explain what they meant by “simple randomization.” The number of participants in each treatment group differed. Demographics for the members of each treatment arm were not provided. Some participants were receiving first-line treatment for a new breast cancer. Others were experiencing a recurrence. Some participants had a modified radical mastectomy, and some had breast-conserving surgery. The authors did not report the use of a power analysis to determine the sample size required to accurately identify statistically significant differences between the treatments, nor the expected effect size of the intervention. It is unlikely that 13 participants in each treatment arm would provide enough power to detect significant differences. The participants in the 3M barrier film versus no treatment and the Elomet (mometasone furoate [steroid] cream) versus no treatment arms served as their own control. The participants in the Elomet versus 3M barrier film arm did not have a control. The volume and type of tissue in each half of the treatment field may not have been identical. The skin dose in each half may have differed and was not reported in this article. Inter-rater reliability was not reported. The method of measuring pain score was not reported.  A pain score of 3 was an endpoint, but the range was not identified.
 

 

Nursing Implications:

The effectiveness of corticosteroids on prevention of radiodermatitis should be investigated further in a large, randomized, controlled clinical trial with adequate power to detect clinically significant differences and controlling for confounding factors.

Shukla, P.N., Gairola, M., Mohanti, B.K., & Rath, G.K. (2006). Prophylactic beclomethasone spray to the skin during postoperative radiotherapy of carcinoma breast: A prospective randomized study. Indian Journal of Cancer, 43, 180–184.

doi: 10.4103/0019-509X.29424
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Study Purpose:

To determine the difference in occurrence of wet desquamation on axillary skin with use of beclomethasone dipropionate spray

Intervention Characteristics/Basic Study Process:

Study participants were randomized to two groups. One group received beclomethasone dipropionate spray on irradiated axilla (200 mcg) seven days a week from day one of radiation therapy. Steroid spray was stopped after development of wet desquamation. The other group was not allowed to apply anything in the irradiated area. Both groups were instructed against using soap, oil, or cream in treatment area; shaving in the irradiated area; and wearing anything other than loose cotton clothing. A clinical examination was done weekly while on treatment.

Sample Characteristics:

  • The study sample (N = 60) was comprised of patients with breast cancer who were receiving loco-regional radiation therapy to the axilla.
  • Median age of the steriod group (n = 30) was 44.6 years, with a range of 28–60 years. Median age of the control group (n = 30)  was 45.9 years, with a range of 29–60 years.
  • ER/PR-positive patients were started on tamoxifen 20 mg daily.

Study Design:

The study used a randomized controlled trial design.

Measurement Instruments/Methods:

  • Radiation-induced skin reaction was graded weekly in terms of erythema, dry desquamation, and wet desquamation until the end of prescribed 50 Gy dose and one month after completion of radiation therapy. Specific method of measurement not reported.
  • Chi-square test was used to see the statistical significance of the difference in wet desquamation on the axillary skin between two arms of the study.

Results:

Wet desquamation of axillary skin at the end of radiation developed in 13.33% of patients in the steroid group and 36.66% of patients in the control group (p = 0.0369). There was no significant difference in median dose of radiation causing wet desquamation (42 versus 43.54 Gy).

Conclusions:

Topical steroid (beclomethasone dipropionate spray) for skin during radiation may reduce risk of wet desquamation of the skin.

 

Limitations:

  • No specific grading scale appears to have been used.
  • No inter- rater reliability testing done.
  • Patients were treated on a telecolbalt unit. A 6 MV photon unit has better skin sparing properties. The d-max of a telecolbalt unit is 5 mm versus 15 mm in a 6 MV photon unit. Findings may not be as applicable to 6 MV photon treatment units.
  • Patient compliance with skincare instructions were not discussed.
  • The sample size was small, with less than 100 patients.

Ulff, E., Maroti, M., Serup, J., & Falkmer, U. (2013). A potent steroid cream is superior to emollients in reducing acute radiation dermatitis in breast cancer patients treated with adjuvant radiotherapy. A randomised study of betamethasone versus two moisturizing creams. Radiotherapy and Oncology, 108, 287–292.  

doi: 10.1016/j.radonc.2013.05.033
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Study Purpose:

To determine if treatment with betamethasone+Essex® cream can decrease acute radiation dermatitis in patients with breast cancer receiving radiation as compared to two emollient creams.

Intervention Characteristics/Basic Study Process:

Patients with breast cancer receiving radiation therapy were randomized 2:1:1 to three treatment groups—betamethasone+Essex cream, Essex cream, or Canoderm® cream. Study creams were applied to the treated skin twice daily for five weeks starting the first week. Treatment continued for two weeks following completion of radiation. Physician/nurse examinations occurred weekly for the first five weeks of treatment.

Sample Characteristics:

  • N = 102  
  • MEDIAN AGE = 62 years
  • AGE RANGE = 28–90 years
  • MALES: 0%, FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Surgery for breast cancer, planned 3D radiation to 50 Gy
  • OTHER KEY SAMPLE CHARACTERISTICS: Aged 18 years or older

Setting:

  • SITE: Single site  
  • SETTING TYPE: Not specified  
  • LOCATION: Ryhov County Hospital, Jonkoping, Sweden

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

  • Randomized, double-blinded

Measurement Instruments/Methods:

The Fitzpatrick skin type scheme I–IV  was used to classify patients as to skin type. Radiation dermatitis was scored using the Radiation Therapy Oncology Group (RTOG) scoring system. A colorimeter measured the redness of the skin at specific areas around the areola. Dryness of skin was measured using a Corneometer®, with scores averaged using five specific locations. Itching, burning, and skin irritation were patient-scored using a visual analog scale (VAS) of 0–10. Quality of life was determined via the Dermatology Life Questionnaire Index on the first and fifth weeks of treatment. Post-radiation follow-up was by phone with symptoms assessed using VAS.

Results:

Significant difference in RTOG skin reaction scoring was noted at week four (p = 0.003) and week five between the betamethasone+Essex cream (investigational group) and two groups treated with moisturizers (control groups). Colorimetry values were not statistically significant but trended with RTOG scores. Corneometer measurements for dry skin were not detectable in any group. In the control groups, Canoderm cream provided improved skin hydration as compared to Essex cream (p = 0.001). Although all groups had worsening itching, burning, and irritation as radiation continued, statistical significance favored the betamethasone group over the control groups (p = 0.048). Patients with skin type I had more pronounced grade 3 reactions, but less in those treated with betamethasone+Essex than controls. Patients with skin type I at week five on the betamethasone+Essex arm had better effect of treatment (p = 0.01). For patients treated to the fossa and/or axilla, RTOG scoring was significantly different for grade 3 occurrence in the betamethasone+Essex arm than controls (p = 0.008). Patients undergoing radiation following mastectomy in the control arms had significantly higher RTOG scores in week five than those in the betamethasone+Essex arm (p < 0.03).

Conclusions:

This study found that prophylactic treatment with betamethasone cream was superior to moisturizing cream for control of acute radiation dermatitis. Because prolonged treatment with topical steroids is known to be able to harm skin integrity, use was limited to seven weeks.

Limitations:

  • Measurement validity/reliability questionable
  • Other limitations/explanation: RTOG scoring of skin toxicity has not been tested for validity and reliability.

Nursing Implications:

Because up to 90% of patients with breast cancer treated with adjuvant radiation have some degree of skin reaction, assessing and treating according to evidence-based practices is important. This study shows use of prophylactic steroid cream to reduce the severity of skin reaction in this group of patients.

Systematic Review/Meta-Analysis

Meghrajani, C.F., Co, H.C., Ang-Tiu, C.M., & Roa, F.C. (2013). Topical corticosteroid therapy for the prevention of acute radiation dermatitis: A systematic review of randomized controlled trials. Expert Review of Clinical Pharmacology, 6, 641–649. 

doi: 10.1586/17512433.2013.841079
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Purpose:

STUDY PURPOSE: To assess the efficacy of topical corticosteroids in the prevention of acute radiation dermatitis compared with placebo, other topical medication, or no treatment

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy:

DATABASES USED: PubMed, Cochrane Library, Ovid, Clinicaltrials.gov, and Google Scholar
 
KEYWORDS: Radiation dermatitis, treatment, prophylaxis, and topical corticosteroid
 
INCLUSION CRITERIA: Randomized controlled trials with parallel study design on topical corticosteroids for the prevention of acute radiation dermatitis (regardless of year of publication), patients with cancer undergoing external radiotherapy for any form of malignancy, male or female, any age. Active treatment arm: topical corticosteroid applied from day one to last day of radiotherapy to prevent radiodermatitis. Comparison arm: placebo, other topical medication, or no treatment.
 
EXCLUSION CRITERIA: Articles not written in English

Literature Evaluated:

TOTAL REFERENCES RETRIEVED: 115
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: All of the articles were independently screened by two of the study authors, who also later reviewed the eligible studies. Of the 115 articles retrieved, 9 were duplicates and another 95 were excluded because they were conducted in animal models, not written in English, not relevant to this review, lab science, case reports, guidelines, or the intervention was not a topical steroid or a combination therapy was used. The data were extracted using the Review Manager (version 5.0) software application that is used for the Cochrane Database.

Sample Characteristics:

  • FINAL NUMBER STUDIES INCLUDED = 6
  • SAMPLE RANGE ACROSS STUDIES: The study sample size spectrum for both arms of the studies ranged from 23–169 participants.
  • TOTAL PATIENTS INCLUDED IN REVIEW: 413
  • KEY SAMPLE CHARACTERISTICS: All studies focused on female patients with breast cancer, ages ranging from 27–89 years, receiving post-operative radiotherapy after modified radical mastectomy or breast conservation surgery with an indication for post-operative radiotherapy. Radiotherapy was administered for an average of 25–39 days at a dose of 50–60 Gy.

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Results:

The primary outcome of the systematic review was the incidence of moist desquamation or grade 3 radiation dermatitis. Only five of the six studies mentioned moist desquamation or grade 3 radiation dermatitis as an outcome. A meta-analysis was performed on the five studies mentioning moist desquamation or grade 3 skin toxicity using Review Manager. Three studies were determined to be at low risk, one at moderate risk, and two were at high risk for bias related to study design. A quantitative synthesis of mean acute radiation dermatitis scores also was done. A pooled analysis was conducted on the five studies. Four studies showed a significant reduction of radiation dermatitis in the topical steroid arm (risk ratio = 0.39; 95% confidence interval: 0.19–0.80; p = 0.01). The risk of developing moist desquamation is 2.5 times less likely with the use of topical steroids. Heterogeneity was not a threat in this study (I2 = 0%).
 
Secondary outcomes of pruritus, burning, and pain were measured in three of the five studies. Pruritus and burning were significantly less (i.e., at least < 0.05) in the steroid arm of two studies. The lessening of pruritus and burning did not reach the p < 0.05 level of significance in the third study. Pain significantly was reduced in only one study.

Conclusions:

Together, the studies showed that the prophylactic application of topical corticosteroids reduced the incidence of moist desquamation and lowered the mean acute radiation dermatitis scores.

Limitations:

  • Use of different steroid medications, potency, and routes of application
  • Differing skin toxicity scales used (e.g., Radiation Therapy Oncology Group, Common Terminology Criteria for Adverse Events)
  • Lack of blinding in some studies
  • Only six studies written in English were included in all levels of the analysis
  • Breast was the only site evaluated

Nursing Implications:

The results of this systematic review and meta-analysis show that topical steroids may be likely to reduce the incidence of radiotherapy-induced moist desquamation of the breast. Additional well-constructed studies consistently implementing blinding and testing the same steroid formulation and route of administration are needed. Studies examining other radiation treatment sites are indicated.

Guideline/Expert Opinion

Wong, R.K., Bensadoun, R.J., Boers-Doets, C.B., Bryce, J., Chan, A., Epstein, J.B., . . . Lacouture, M.E. (2013). Clinical practice guidelines for the prevention and treatment of acute and late radiation reactions from the MASCC Skin Toxicity Study Group. Supportive Care in Cancer, 21, 2933–2948. 

PROFESSIONAL GROUP: Multinational Association for Supportive Care in Cancer (MASCC) Skin Toxicity Study Group

doi: 10.1007/s00520-013-1896-2
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Purpose & Patient Population:

PURPOSE: To develop evidence-based guidelines to prevent and treat skin toxicity (acute and late) from radiation therapy. Use of these guidelines was intended for practitioners who encounter patients with skin changes associated with radiation therapy.
 
TYPES OF PATIENTS ADDRESSED: Patients who have received or will receive radiation therapy

Type of Resource/Evidence-Based Process:

RESOURCE TYPE: Evidence-based guideline
 
PROCESS OF DEVELOPMENT: The Skin Toxicity Study Group is one of 17 study groups of the Multinational Association for Supportive Care in Cancer (MASCC). The first original search was from 1980–2004 and was used by the Cancer Care Ontario guideline group. This search was updated in 2010 for a book chapter on radiation dermatitis, including the original search strategy from 1980–2004 in addition to a search without language restriction for 2004–August 2010. For the MASCC guideline, a second update from 2010–April 2011 was conducted for the meeting. A final update was completed in July 2012 prior to publication of the manuscript.

DATABASES USED: MEDLINE for initial and subsequent updates; PreMEDLINE, Cochrane Library, and CANCERLIT for the original search 1980–2004; Embase for 2010–2012; and conference proceedings of the American Society of Clinical Oncology for 2004–2012. National Guidelines Clearinghouse was used for existing practice guidelines.

KEYWORDS: Radiation dermatitis for acute reactions; telangiectasia and cutaneous fibrosis for late reactions

INCLUSION CRITERIA: Randomized controlled trials, guideline papers, meta-analyses, and systematic reviews. Studies that included any control group met the definition of a controlled study. Inclusion required that grade of skin reaction was evaluated as an outcome with primary interest greater or equal to moist desquamation. Pain, itching, and quality of life also were included if available. For late reaction dermatitis, trials using prospective designs were used.

EXCLUSION CRITERIA: Unpublished articles

Phase of Care and Clinical Applications:

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference:

Acute radiation dermatitis recommendations were based on guidelines consisting of four general systematic reviews, two for specific topics, two evidence-based guidelines, and one consensus guideline. There were 56 randomized controlled trials–45 prevention, 9 treatment, and 1 combined prevention and treatment. Late radiation effect recommendations were based on one RCT; one prospective, observational study; and two prospective, single-arm studies.

Guidelines & Recommendations:

Strong recommendation:
  • Gentle washing with water (mild soap or shampoo optional)
  • Antiperspirants during breast radiation therapy
  • Prophylactic topical steroids (mometasone) for risk reduction of discomfort and itching
 
Weak recommendation:
  • Prophylactic silver sulfadiazine cream in patients with breast cancer to reduce radiation dermatitis score
 
Strong recommendation against:
  • Prophylactic aloe vera or trolamine
 
No recommendation possible:
  • Prophylactic topical sulcrate/derivatives, hyaluronic acid, ascorbic acid, silver leaf dressing, LED, Theta-Cream, dexpanthenol, and calendula
  • Oral proteolytic enzymes, sucralfate, zinc, and pentoxifylline in standard clinical practice
 
Established radiation-induced telangiectasia and fibrosis:
  • Weak recommendation for pulse dye laser for visual appearance
  • Weak recommendation against pentoxifylline for reduction of fibrosis in standard clinical practice
 
Patient education materials:
  • Validation prior to use
  • Sixth grade reading level and tables preferred
  • Specific products to purchase with examples
  • Behaviors to avoid
  • Contact information for physician and when to call for symptom management

Nursing Implications:

Nurses need to keep updated on current studies and guidelines related to care of patients receiving radiation therapy as well as potential acute and long-term effects to the skin. Nurses are in a unique position to educate staff and patients on evidenced-based skin care. Potential skin care practices for patients undergoing radiation need to be evaluated through well-designed research studies.


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