Trolamine (Biafine®)

Trolamine (Biafine®)

PEP Topic 
Radiodermatitis
Description 

Trolamine is an oil-in-water emulsion with nonsteroidal anti-inflammatory properties that heals wounds by recruiting macrophages to the wound bed and promoting the production of granulation tissue. Biafine has been studied in radiodermatitis.

Effectiveness Unlikely

Guideline/Expert Opinion

Bolderston, A., Lloyd, N.S., Wong, R.K.S., Holden, L., Robb-Blenderman, L., & Supportive Care Guidelines Group. (2005). The prevention and management of acute skin reactions related to radiation therapy: A clinical practice guideline (Practice Guidelines Report #13-7). Toronto, Canada: Cancer Care Ontario. Retrieved from https://www.cancercare.on.ca/common/pages/UserFile.aspx?fileId=34406.

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Purpose & Patient Population:

To develop practice guidelines answering two questions:

  1. What are the optimal methods to prevent acute skin reactions related to radiation therapy (RT) within the first six months of irradiation?
  2. What are the optimal methods to manage acute skin reactions related to RT?

Type of Resource/Evidence-Based Process:

Databases searched were PreMEDLINE, MEDLINE, CANCERLIT, and Cochrane Library between January 1980 and April 2004. The name of the initiative was the Cancer Care Ontario’s Program in Evidence-Based Care. The method used was the practice guidelines development cycle. Articles were included based on rigorous inclusion criteria (meta-analysis, systematic reviews, evidence-based practice guidelines, comparative studies, prospectively collected data in at least one trial arm, studies with reported outcomes—degree of skin reaction [using a validated skin reaction tool] and other outcomes reported and articles available as published articles or abstract reports). Exclusion criteria were also identified.

The systematic review included interprofessional members from the Supportive Care Guidelines Group of Cancer Care Ontario and the Program in Evidence-Based Care, an internationally recognized program at McMaster University, Hamilton, Ontario, Canada.

No conflict of interest was identified.

A systematic review of 28 clinical trials was included in analyses; 23 pertained to prevention and 5 addressed management of skin reactions. Two practice guides were reviewed:  Oncology Nursing Society and British Columbia Cancer Agency (expert opinion and consensus).

Results Provided in the Reference:

A table of clinical studies presented study descriptions and outcomes of the trials on prevention and management of skin reactions, pain, and itching.

The largest randomized trial compared calendula versus Biafine and was significant (p = 0.03) in reducing the severity of RT dermatitis.

Guidelines & Recommendations:

  • Gentle skin washing with water alone or mild soap (unscented, lanolin-free) and water
  • Gentle shampooing of the scalp with mild shampoo if receiving RT to the head
  • Encourage personal hygiene habits to avoid psychosocial distress. Limiting personal hygiene practices is not recommended.
  • Patients who received breast irradiation may use calendula ointment to decrease the occurrence of a grade 2 or higher skin reaction.

Nursing Implications:

Insufficient evidence existed to support or refute the use of

•Topical agents (corticosteroids, sucralfate cream, Biafine® (Ortho Dermatologics), ascorbic acid, aloe vera, chamomile cream, almond ointment, or polymer adhesive skin sealant)
•Oral agents (enzymes, sucralfate)
•Intravenous agents (amifostine)

Gentle skin and hair washing should be unrestricted in patients receiving RT. No barrier exists to using mild soap.

No trials answered the question on management.

Future Research:

  • Outcome assessment tools are required, including quality of life tools.
  • Trials to assess oral enzymes are needed to confirm studies showing potential for prevention benefit.
  • Randomized trials are needed (double-blinded, randomized, controlled trials) about the benefits of moisturizing cream as a preventive measure.
  • Randomized trials are needed that address moist desquamation management with the use of dressings as an intervention.
  • Trials are needed that explore sites with different risk factors and possible differing management.

Opinions of This Group:

  • Use plain, unscented, lanolin-free hydrophilic cream, but discontinue with skin breakdown.
  • Low-dose corticosteroid cream may be helpful with itching and irritation, but caution patients about overuse. More evidence is required to make firm recommendations.

Research Evidence Summaries

Elliott, E. A., Wright, J. R., Swann, R. S., Nguyen-Tân, F., Takita, C., Bucci, M. K., . . . Radiation Therapy Oncology Group Trial 99-13. (2006). Phase III trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13. Journal of Clinical Oncology, 24, 2092–2097.

doi: 10.1200/JCO.2005.04.9148
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Study Purpose:

This phase 3 trial was designed to compare an emulsion containing trolamine against usual supportive care within each participating institution.

Intervention Characteristics/Basic Study Process:

Patients were randomly assigned to one of three treatment arms:  (a) prophylactic trolamine emulsion, (b) interventional trolamine emulsion, and (c) declared institutional preference.

In both trolamine arms, trolamine was applied at four-hour intervals. Patients were instructed to maintain at least four hours between trolamine and radiation therapy (RT).

Trolamine use was discontinued immediately if an allergic reaction occurred or if grade 3 dermatitis was reported in any area larger than 1.5 cm of confluent desquamation or bleeding in the treatment area.

Sample Characteristics:

  • The sample was comprised of 547 patients (79% male).
  • Mean age was 59 years.
  • Patients had head and neck cancer.
  • Approximately 80% of the patients received an RT dose greater than 60 Gy.
  • Of the patients, 53% on study received combined-modality treatment.

Setting:

Fifty-one institutions in various states in the United States

Study Design:

The study was a randomized, controlled trial.

Measurement Instruments/Methods:

  • The primary outcome was the reduction in grade 2 or higher skin toxicity, per National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2 and the ONS toxicity scoring tool.
  • Secondary outcomes included patient-reported quality of life (QOL).
  • Skin assessments and QOL forms were completed before RT, weekly during RT, and weekly for four weeks after RT.
  • The Spitzer QOL Index (SQOLI) and the Head and Neck Radiotherapy Questionnaire (HNRQ) were used to measure QOL. A higher score indicated greater toxicity and poorer QOL.

Results:

  • The rates of grade 2 or higher radiodermatitis were 79%, 77%, and 79% in the prophylactic, interventional, and institutional preference arms, respectively.
  • Rates of grade 3 or 4 dermatitis did not differ, with rates of 25%, 25%, and 23% in the three arms, respectively.
  • Confluent moist desquamation was observed in 7%, 10%, and 8% of patients in the prophylactic, interventional, and institutional preference arms, respectively.
  • Ulceration, hemorrhage, and necrosis were experienced in 2%, 3%, and 1% of the patients in the three arms, respectively.
  • The ONS toxicity score reported a small to moderate amount of moist desquamation in 31%, 28%, and 34% of patients in the prophylactic, interventional, and institutional preference arms, respectively.
  • No significant differences were found in QOL.
  • Fourteen products were reported as standard of care. The most commonly used product was Aquaphor, which was the institutional preference for 39% of the patients.
  • A slightly higher rate of treatment breaks was reported in the institutional arm than in both trolamine arms for current and former smokers, but the breaks on average were shorter.

Conclusions:

The results demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiodermatitis or improving patient-reported QOL.

Limitations:

  • Absence of patient diaries to record compliance with application directions, the timing and number of applications, and the full amount of product used was a limitation. The product log for this trial was a record of the number of tubes supplied to each participant.
  • The study was not blinded or placebo-controlled, which introduced the possibility that the skin grading and QOL assessments were subject to reviewer and patient bias.

Fenig, E., Brenner, B., Katz, A., Sulkes, J., Lapidot, M., Schachter, J., … Gutman, H. (2001). Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial. Oncology Reports, 8, 305–309.

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Study Purpose:

To evaluate the use of Biafine or Lipiderm to prevent radiodermatitis.

Intervention Characteristics/Basic Study Process:

Participants were randomized to one of three trial arms:  (a) Biafine, (b) Lipiderm, or the (c) control (no prophylactic treatment).

Study preparations were applied twice daily, staring 10 days prior to the beginning of radiation therapy (RT) and continuing until 10 days after treatment. Skin treatment was upgraded if necessary to steroids for grade 3 reaction antibiotics for grade 4 reactions or pause in therapy for grade 5 reactions.

Sample Characteristics:

  • The sample was comprised of 74 women.
  • Mean age was 69 years (range 42–85).
  • Patients had T1-T2N0M0 breast cancer.
  • Of the patients, 63% received concomitant tamoxifen.
  • Patients with a complicated surgical wound or history of skin conditions were excluded.

Setting:

Single site

Study Design:

The study was a randomized, controlled trial.

Measurement Instruments/Methods:

  • The Radiation Therapy Oncology Group (RTOG) skin toxicity scale was used.
  • Impressions were measured by an evaluation questionnaire using the same criteria. Relevant data were reported as a grade of reaction.
  • Overall treatment success was determined by maximal treatment grade, total number of RT gaps needed, the patients’ weekly impressions, the radiotherapists' clinical impressions, and the study nurses’ impressions.
  • Pearson correlation, chi-square, or Fisher exact tests were used to analyze the relationships between the three study arms.

Results:

  • No objective data revealed an advantage in the Biafine or Lipiderm arms.
  • Maximum skin treatment level was lower in the two intervention arms but was not significant.
  • Patients in both intervention arms reported high levels of satisfaction (Biafine 86%, Lipiderm 85%).

Conclusions:

The study neither refutes nor supports use of these products for existing reactions. These products did not show radioprotective effects.

Limitations:

  • The study groups were too small to demonstrate any differences among study arms.
  • Rubbing effects may have caused tissue damage.
  • There were several responsible graders:  radiation therapist, nurses, and patients. Interrater reliability of the measurements was not addressed.

Fisher, J., Scott, C., Stevens, R., Marconi, B., Champion, L., Freedman, G. M., … Wong, G. (2000). Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97–13. International Journal of Radiation Oncology, Biology, Physics, 48, 1307–1310.

doi: 10.1016/S0360-3016(00)00782-3
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Study Purpose:

To determine if Biafine was more effective than best supportive care (BSC) in preventing or reducing radiation (RT)-induced dermatitis.

Intervention Characteristics/Basic Study Process:

Randomizaton to Biafine versus BSC depended on the institution and included aloe, Aquaphor, other interventions, and no treatment.

Patients were stratified by bra size:  small (32ab, 34ab, 36a), medium (32c, 34c, 36bc, 38abc), or large (all others).

Sample Characteristics:

  • The sample was comprised of 172 women.
  • Median age was 62 years for both groups.
  • Patients had breast cancer and were not undergoing chemotherapy.
  • Dose was 50 to 59 cGy versus 59 to 64 cGy.

Setting:

  • Dearborn, Michigan
  • Philadelphia, Pennsylvania
  • White Plains, New York
  • Newark, Delaware
  • San Francisco, California
  • Baltimore, Maryland
  • Ann Arbor, Michigan
  • Joliet, Illinois
  • Albuquerque, New Mexico

Study Design:

The study was a randomized, controlled trial.

Measurement Instruments/Methods:

  • Radiation Therapy Oncology Group (RTOG) toxicity scale weekly and at two and six weeks after RT
  • Maximum toxicity was determined to be the worst skin toxicity observed.
  • Weekly completion of the Spitzer QOL questionnaire and patient satisfaction

Results:

  • There was no overall difference in maximum toxicity between the treatment arms during RT.
  • No statistical difference was found between arms in the time grade 2 toxicity.
  • All had resolution by week 9.
  • Large breasted women receiving Biafine were more likely to have no toxicity week 6 after RT (p = 0.002).
  • There was an interaction with treatment healing and tobacco use. Smokers in the Biafine arm had 26% no toxicity in follow-up, and smokers in BSC had 57% no toxicity in follow-up (p = 0.06). Those who never smoked and received Biafine had no skin toxicities at 6-week follow-up (p = 0.026).

Limitations:

  • Rater bias occurred.
  • The authors did not state who rated the patients and what training occurred.
  • The authors did not state if patients were checked the same day every week or at the beginning of each patient week.
  • The authors did not record what the application technique was and if it was the same across the different institutions.

Gosselin, T. K., Schneider, S. M., Plambeck, M. A., & Rowe, K. (2010). A prospective randomized, placebo-controlled skin care study in women diagnosed with breast cancer undergoing radiation therapy. Oncology Nursing Forum, 37, 619–626.

doi: 10.1188/10.ONF.619-626
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Study Purpose:

To compare the effectiveness of three products in reducing the incidence of radiodermatitis.

Intervention Characteristics/Basic Study Process:

Women were randomly assigned to placebo (sterile water mist), Aquaphor, Biafine, or radiacare gel. Patients were instructed to apply the product two times daily with the start of radiation therapy (RT) and until treatment was complete.  Patients were not to use any other skin care product on the affected area. The radiation nurse assessed patients weekly and reminded them to complete their home journals. The investigators conducted independent skin assessments on a random sample of 10% of patients to establish reliability of the observations.

Sample Characteristics:

  • The sample was comprised of 208 women. 
  • Mean age across all groups ranged from 54 to 56 years.
  • Patients had stage 1 and 2 breast cancer.
  • Median dose was 200 cGy daily, and total dose was 6200 cGy most often.
  • The average number of treatments was 31.

Setting:

  • Single site 
  • Outpatient  
  • Duke

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Study Design:

The study was a double-blind, placebo-controlled, randomized, four-group trial.

Measurement Instruments/Methods:

  • Radiation Therapy Oncology Group (RTOG) skin toxicity scoring
  • Patient journal of application, satisfaction, and ease of use

Results:

Of the patients, 95% had a skin reaction, with most occurring by week 4. No product tested showed a significant difference in reducing the incidence of grade 2 to 4 skin toxicity compared to placebo. Increases in the proportion with a skin reaction were greatest among those using Biafine. Increases in skin reactions were similar to each other in the other study groups. Patient adherence to use was greater than 80% during the study.

Conclusions:

 No product tested was better than placebo in reducing the incidence of grade 2 to 4 radiodermatitis.

Nursing Implications:

Biafine, Aquaphor, and radiacare gel were no more effective than placebo in reducing the incidence of clinically relevant skin toxicity with RT in patients with breast cancer. Biafine was associated with the greatest increase in toxicity across groups. Findings suggested that none of these products are effective, although a systematic review and meta-analysis in this area suggests that using anything is more effective than using nothing. Further well-designed research in prevention and management of radiodermatitis is needed.

Pommier, P., Gomez, F., Sunyach, M. P., D’Hombres, A., Carrie, C., & Montbarbon, X. (2004). Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. Journal of Clinical Oncology, 22, 1447–1453.

doi: 10.1200/JCO.2004.07.063
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Study Purpose:

To assess the effectiveness of Calendula for the prevention of acute radiation (RT)-induced dermatitis of grade 2 or higher during RT compared with trolamine (Biafine).

Intervention Characteristics/Basic Study Process:

  • Patients were randomly allocated to application of trolamine (n = 128) or Calendula (n = 126) on irradiated fields after each session.
  • Patients started topical application of ointment on irradiated skin at onset of RT, twice a day or more, depending on the occurrence of dermatitis and pain, until completion of RT.
  • Patients were instructed not to use agents two hours or less before an irradiation session or before treatment evaluation.
  • No other prophylactic creams, lotions, or gels were allowed.
  • Physicians were free to treat established dermatitis, grade 2 or higher, or allergy as considered appropriate.
  • Clinicians were blinded to the treatment used.

Sample Characteristics:

  • The sample was comprised of 254 women (Calendula, 128; trolamine, 126).
  • Mean age was 56.5 years in the Calendula arm and 55.1 years in the trolamine arm (range 26.5–74.5). 
  • Patients were post lumpectomy or mastectomy for nonmetastatic breast cancer.
  • Patients were undergoing treatment with or without adjuvant postoperative chemotherapy or hormonal treatment.
  • Standard irradiation fractionation (2 Gy per session, five sessions per week) was used.
  • Patients who underwent lumpectomy received 52 Gy from two tangential fields to the whole breast with 10 Gy boost to the tumor bed.
  • Patients who underwent mastectomy received 46 Gy to the chest wall.
  • If relevant, internal mammary and supraclavicular nodes were irradiated.

Setting:

  • Single site
  • Centre Leon Berard, Lyon, France

Study Design:

The study was a randomized, blinded, controlled trial.

Measurement Instruments/Methods:

  • Once weekly acute dermal toxicity was evaluated according to the Radiaton Therapy Oncology Group (RTOG) scale.
  • Pain was assessed weekly on a 10-cm visual analog scale (VAS). The occurrence, duration, and reasons for interruption of RT or of allocated cream application were registered, as were allergic reactions and quantity of agents used, until completion of RT.
  • At study end, patients completed a questionnaire to assess satisfaction with respect to ease of application, pain, and dermatitis relief.
  • Qualitative measures were compared to the chi-square test or Fisher exact test, as appropriate.
  • For quantitative measures, Student’s t-test or Wilcoxon-Mann-Whitney test was used.

Results:

  • The occurrence of acute dermatitis of grade 2 or higher was significantly lower (41% versus 63%; p < 0.001) with the use of Calendula versus trolamine.
  • Twenty patients given trolamine presented with grade 3 toxicity (p = 0.034).
  • Benefits were most marked at sites at risk of maceration (submammary fold, armpit, and tangential area) and sites with thin skin.
  • Patients receiving Calendula had less frequent interruption of RT. Mean length of treatment interruption was 10 days (range 2–22 days). Fifteen treatment interruptions were observed in the trolamine group; 12 were due to skin toxicity.
  • No allergic reactions were observed in the Calendula group, whereas four patients in the trolamine group developed the allergic-type reactions of pruritus and urticaria.
  • Patients receiving Calendula had significantly reduced RT-induced pain.
  • Mean maximal pain evaluated in the Calendula group was 1.54 and 2.10 in the trolamine group (p = 0.03).
  • Self-assessed satisfaction was greater with Calendula.
  • Prevention of erythema:  69% Calendula versus 39% trolamine.
  • Prevention of pain:  65% with Calendula versus 46% trolamine.
  • Calendula was considered more difficult to apply as noted by 30% of the calendula group versus 5% of the trolamine group.
  • The risk of skin toxicity of grade 2 or higher was significantly increased for women whose body mass index was ≥25 kg/m2 (p < 0.001) and for women who had received chemotherapy before RT after a lumpectomy (p = 0.01), and for those using trolamine (p < 0.001).

Limitations:

  • A delivered dose of 61 Gy or less was not identical in the treatment groups, favoring the Calendula group over the trolamine group.
  • Because of differences in texture, color, and smell, it was not possible to perform a double-blind, randomized study. Simple blinding of the clinician removed bias with respect to the main objective of the study.

Szumacher, E., Wighton, A., Franssen, E., Chow, E., Tsao, M., Ackerman, I., … Hayter, C. (2001). Phase II study assessing the effectiveness of Biafine cream as a prophylactic agent for radiation-induced acute skin toxicity to the breast in women undergoing radiotherapy with concomitant CMF chemotherapy. International Journal of Radiation Oncology, Biology, Physics, 51, 81–86.

doi: 10.1016/S0360-3016(01)01576-0
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Study Purpose:

To assess the efficacy of Biafine cream in preventing grade 2 acute radiodermatitis.

Intervention Characteristics/Basic Study Process:

  • Biafine cream was applied twice daily to the skin within the treatment field, starting on first day of radiation therapy (RT) treatment and ending two weeks after RT.
  • No application of ointment within four hours prior to RT was allowed.
  • No other prophylactic agents were to be applied to the RT field during the course of RT.
  • Application of ointment was permitted within four hours before RT.
  • Patients were given general skin care recommendations at the start of RT.
  • Patients who developed grade 2 radiodermatitis had the option to withdraw from study and be treated with other topical agents or to continue with Biafine cream.

Sample Characteristics:

  • The sample was comprised of 60 women.
  • Median age was 49 years (range 25–77).
  • Patients had breast cancer and were treated with lumpectomy.
  • Treatment lasted for five weeks, with a total dose of 5,000 cGy in 200 cGy fractions and no boost.
  • Patients were treated on a 6-mv photon accelerator.
  • All patients wer treated with concomitant adjuvant chemotherapy.

Setting:

Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada

Phase of Care and Clinical Applications:

Skin within the RT field was examined before the initiation of RT, at weekly intervals, and at two and four weeks after treatment by a radiation oncologist or a dedicated radiation technologist.

The Skin Assessment Questionnaire was scored according to the National Cancer Institute of Canada skin radiation toxicity criteria.

The self-administered questionnaire incorporated items from the instrument developed for the Ontario Clinical Oncology Group trial of hypofractionated RT after lumpectomy in women with node-negative breast cancer.

Study Design:

The study was an exploratory, phase II, intervention trial.

Measurement Instruments/Methods:

  • Maximum skin toxicity observed during the five-week course of treatment was:
    • Less than grade 2 toxicity (15%; n = 9)
    • Grade 2 (83%; n = 50)
    • Grade 3 (2%; n = 1)
    • Grade 4 (0%; n = 0).
  • The majority of dermatitis was observed after three weeks of RT.
  • Eight patients started Flamazine™ (Smith & Nephew, Inc.) cream with grade 2 desquamation.
  • Most patients subjectively felt that Biafine cream was soothing.
  • No treatment delays or interruptions were observed due to skin toxicity.

Results:

The majority of patients who underwent concomitant chemotherapy and RT for breast cancer developed grade 2 radiodermatitis with the use of Biafine cream.

Limitations:

  • There was a wide range of RT start times from the start of chemotherapy.
  • It was not possible to compare to a control group to determine comparative effects.

Systematic Review/Meta-Analysis

Kumar, S., Juresic, E., Barton, M., & Shafiq, J. (2010). Management of skin toxicity during radiation therapy: a review of the evidence. Journal of Medical Imaging and Radiation Oncology, 54, 264–279.

doi: 10.1111/j.1754-9485.2010.02170.x
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Purpose:

To review the evidence for skin care management and conduct a survey to assess current practices in Australia and New Zealand.

Search Strategy:

Databases searched were MEDLINE, PubMed, CINAHL, Google Scholar, and Google search. Searches were also completed by hand for the time period of 1980 to 2008.

Search keywords were radiation dermatitis, skin reaction, management, skin care, skin toxicity, moist desquamation, dry desquamation, erythema, sorbolene aqueous cream, and aloe vera.

Inclusion and exclusion criteria were not specified.

Literature Evaluated:

Thirty-one references were retrieved. Literature was evaluated on the basis of sample size. Meta-analysis was performed on studies reporting at least grade II skin toxicity.

Sample Characteristics:

  • The final number of studies included was 31.
  • The sample size across studies was 3,174 participants (range 413–506).
  • Participants had various tumor types.
  • All participants received radiation therapy (RT).

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Results:

Findings were reviewed for washing, topical aloe vera, topical sucralfate, Biafine cream, corticosteroids, hyaluronic acid, barrier film, dressings, and wheatgrass extract for prophylaxis. For management, interventions included were topical steroid cream, sucralfate, and dressings. Meta-analysis across studies using any topical prophylaxis showed that any intervention was associated with lower odds of development of skin toxicity (p = 0.02). There were no significant results for management interventions. There was consistent evidence in favor of gentle washing with mild soap during RT. There was some evidence in support of corticosteroids, bepanthan, topical hyaluronic acid, calendula, and barrier films. Aloe vera was associated with higher toxicity.

Conclusions:

Evidence did not support the use of sucralfate, Biafine, or dressing for prevention. Evidence regarding interventions for management of skin toxicity was conflicted, and none produced significant effects. Findings support the use of washing. There was some evidence in support of using corticosteroids, bepanthan, barrier films, calendula, and topical hyaluronic acid. Findings suggest that use of any topical therapy for prophylaxis may be more effective than no intervention.

Limitations:

  • Analysis was limited by combining all types of interventions together, which did not allow for differentiation between those agents individually shown to be effective and not effective.
  • Methods for evaluation of the quality of the research were not well described or incorporated into the analysis. 
  • Findings regarding management were questionable because of high heterogeneity among studies included in the meta-analysis. 
  • Actual odds ratios or effect sizes from the meta-analysis were not reported. 
  • Final recommendations stated by the authors were not consistent with the rest of the conclusions stated elsewhere in the article. 
  • The basis for recommendations, concerning evaluation of the quality of the evidence, was not clear. 
  • The authors stated that they weighted studies by sample size, but this method was not described.

Nursing Implications:

Washing during RT should not be restricted. There is some evidence in support of using calendula, hyaluronic acid, no-sting barrier film, bepanthan, and topical steroids. Evidence does not support the use of aloe vera.

Salvo, N., Barnes, E., van Draanen, J., Stacey, E., Mitera, G., Breen, D., . . . De Angelis, C. (2010). Prophylaxis and management of acute radiation-induced skin reactions: A systematic review of the literature. Current Oncology (Toronto, Ont.), 17(4), 94–112.

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Purpose:

To review the evidence for approaches to prevention and management of radiodermatitis

Search Strategy:

Databases used were MEDLINE, PubMed, and Cochrane Library. Keywords searched were skin reactions, radiation, radiation adverse effects, erythema, desquamation, and radiodermatitis. Studies were included in the review they

  • Were published reports or abstracts from January 1, 2000 to October 1, 2008.
  • Reported the method of skin grading.

Studies were excluded from the review if they were letters, comments, editorials, case reports, practice guidelines, systematic reviews, or meta-analyses.
 

Literature Evaluated:

The total references retrieved and the quality rating approach were not reported.
 

Sample Characteristics:

  • Thirty-nine trials were included in the review.
  • Patients were receiving radiation therapy.

Phase of Care and Clinical Applications:

Patients were undergoing active antitumor treatment.

Results:

Washing practice, topical corticosteroids, aloe vera, biafine, hyauronidase-based creams, sucralfate, miscellaneous creams, Amifostine, oral enzymes, pentosifylline, dressings, non-steroidal topical cream, topical colony-stimulating factors supplements, and mode of radiation delivery were reviewed. Other agents studied included beladonna 7CH and a Chinese remedy, lian bai liquid.

Conclusions:

There is lack of support for Biafine use. There is some evidence to suggest that topical corticosteroids may be beneficial. Evidence for non-steroidal topical agents is conflicting. Evidence does not support use of Aloe Vera or sucralfate cream. Some evidence to suggest that light-emitting diode, pentoxifylline, sliver-leaf dressings, washing, zinc supplements and intensity-modulated radiation therapy are beneficial.

Limitations:

  • The trials were small and had numerous design and reporting limitations.
  • Secondary trials evaluated the same agent or treatment, making comparison very difficult.

Nursing Implications:

Further research is needed in this area. Intervention goals, prevention or treatment need to be clear and further work is needed to develop and validate more sensitive assessment tools. Further work is also needed to evaluate differences in risk based on anatomical sites.


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