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

Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1307-10. doi: 10.1016/s0360-3016(00)00782-3.

Abstract

Purpose: To determine if Biafine compared to Best Supportive Care (BSC) is effective in minimizing or preventing radiation-induced dermatitis in women undergoing breast irradiation.

Methods and materials: Patients were randomized between Biafine (n = 83) vs. BSC (n = 89). The institutions identified preference for BSC at the time of randomization. A no-treatment arm was allowed (16% received no treatment). Patients were instructed to apply randomized product three times a day, but not within 4 h of their daily RT session. Application began following their first radiation treatment and continued 2 weeks postradiation. Skin dermatitis was scored weekly utilizing the RTOG and ONS (Oncology Nursing Society) skin toxicity scales, a weekly patient satisfaction and quality-of-life questionnaire.

Results: Using the RTOG toxicity scale there was no overall difference for maximum dermatitis during RT between Biafine and BSC (p = 0.77). There was no difference in maximum toxicity by arm or breast size. There was an interaction between breast size and toxicity, with large-breasted women exhibiting more toxicity. Large-breasted women receiving Biafine were more likely to have no toxicity 6 weeks post RT.

Conclusion: There was no overall difference between BSC and Biafine in the prevention, time to, or duration of radiation-induced dermatitis.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study
  • News
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Aloe / therapeutic use*
  • Breast Neoplasms / radiotherapy*
  • Chemotactic Factors / therapeutic use
  • Dermatologic Agents / therapeutic use*
  • Female
  • Gels
  • Humans
  • Macrophages
  • Middle Aged
  • Phytotherapy*
  • Plants, Medicinal*
  • Radiodermatitis / drug therapy*

Substances

  • Chemotactic Factors
  • Dermatologic Agents
  • Gels