title: 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.
abstract: OBJECTIVE
  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
  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.
  
  
  CONCLUSIONS
  There was no overall difference between BSC and Biafine in the prevention, time to, or duration of radiation-induced dermatitis.
authors: Radiation Oncology Center, Oakwood Hospital and Medical Center, Dearborn, MI 48123, USA. fisherj@oakwood.org
authors: J
authors: J
authors: Fisher
authors: C
authors: C
authors: Scott
authors: R
authors: R
authors: Stevens
authors: B
authors: B
authors: Marconi
authors: L
authors: L
authors: Champion
authors: G M
authors: GM
authors: Freedman
authors: F
authors: F
authors: Asrari
authors: M V
authors: MV
authors: Pilepich
authors: J D
authors: JD
authors: Gagnon
authors: G
authors: G
authors: Wong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000504:Aloe / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000532:radiotherapy*; D002630:Chemotactic Factors / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D008264:Macrophages; D008875:Middle Aged; D008517:Phytotherapy; D010946:Plants, Medicinal; D011855:Radiodermatitis / Q000188:drug therapy*
chemical_list: D002630:Chemotactic Factors; D003879:Dermatologic Agents; D005782:Gels