Effectiveness Not Established
Research Evidence Summaries
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.
To evaluate of the use of Biafine or Lipiderm to prevent radiodermatitis
Intervention Characteristics/Basic Study Process:
Participants were randomized to one of three trial arms: Biafine, Lipiderm, or control (no prophylactic treatment). Study preparations were applied twice daily, starting 10 days prior to the beginning of radiation therapy and continuing until 10 days after treatment. Skin treatment was upgraded if necessary to steroids (grade 3 reaction), antibiotics (grade 4 reaction) or pause in therapy (grade 5 reaction).
- The study sample (N = 74) was comprised of female patients with breast cancer.
- Mean age was 69 years, with a range of 42–85 years.
- Of patients in the study, 63% were receiving concomitant tamoxifen.
The study took place at a single site.
The study used a randomized controlled trial design.
- The Radiation Therapy Oncology Group and European Organisation for the Research and Treatment of Cancer skin toxicity scale was used
- Overall treatment success was determined by maximal treatment grade, total number of radiation treatment gaps needed, the patients’ weekly impression, the radiotherapists clinical impression, and the study nurses’ impression.
- Impressions were measured by an evaluation questionnaire using the same criteria. Relevant data were reported as a grade of reaction.
- Pearson correlation, Chi-square or Fisher’s exact tests were used to analyze relationships among the three study arms.
- No objective data revealed an advantage in the Biafine or Lipiderm arm.
- The maximum skin treatment level was lower in the two intervention arms, but was not significant.
- Patients in both intervention arms reported a high level of satisfaction (Biafine 86% and Lipiderm 85%).
The study does not refute or support use of these products for an existing skin reaction and did not show a radioprotective effect.
- The study groups were too small to demonstrate any differences among study arms.
- Rubbing effects may have cause tissue damage.
- Radiation therapists, nurses, and patients were all responsible for granding, which affects the reliability of data.
- There was no mention of whether addition treatments were used as allowed.