The Preventive Effects of Boron-Based Gel on Radiation Dermatitis in Patients Being Treated for Breast Cancer: A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Oncol Res Treat. 2022;45(4):197-204. doi: 10.1159/000520363. Epub 2022 Jan 3.

Abstract

Introduction: Radiation dermatitis (RD) is a side effect of radiation therapy (RT) which is experienced by over 90% of patients being treated for breast cancer. The current clinical trial was conducted to measure the preventative effects of a boron-based gel on several different clinical outcomes (dermatitis, erythema, dry desquamation, and moist desquamation) after 25 radiotherapy sessions.

Methods: This research used a double-blind parallel-group design with a placebo control (n = 76) and randomized group (n = 181), with all participants being between 18 and 75 years old. Fifteen minutes before each radiotherapy, participants in the intervention group were given a gel containing 3% sodium pentaborate pentahydrate, while those in the placebo group received a gel with no chemical substance. Dermatitis, erythema, dry desquamation, and moist desquamation were compared between the 2 groups.

Results: At baseline, there were no significant differences between the groups (p > 0.05), except for body mass index. After 14 days of treatment, dermatitis (98.7% vs. 9.9%; p < 0.001), erythema (96.1% vs. 12.2%; p < 0.001), dry desquamation (50% vs. 3.9%; p < 0.001), and moist desquamation (18.4% vs. 0.6%; p < 0.001) were much more common in the placebo group than the intervention group. To prevent dermatitis, erythema, dry desquamation, and moist desquamation in 1 patient, on average, 1.1 (95% confidence interval [CI]: 1.1-1.2), 1.2 (95% CI: 1.1-1.3), 2.2 (95% CI: 1.7-2.9), and 5.6 (95% CI: 3.8-11.0) patients need to be treated, respectively.

Conclusion: The boron-based gel has a significant preventive effect on several categories of RD which might be used by clinicians in breast cancer.

Keywords: Boron; Breast neoplasms; Epidemiology; Radiodermatitis.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Boron / therapeutic use
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / radiotherapy
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Radiodermatitis* / drug therapy
  • Radiodermatitis* / etiology
  • Radiodermatitis* / prevention & control
  • Young Adult

Substances

  • Boron