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

Abstract

<b><i>Introduction:</i></b> 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. <b><i>Methods:</i></b> This research used a double-blind parallel-group design with a placebo control (<i>n</i> = 76) and randomized group (<i>n</i> = 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. <b><i>Results:</i></b> At baseline, there were no significant differences between the groups (<i>p</i> > 0.05), except for body mass index. After 14 days of treatment, dermatitis (98.7% vs. 9.9%; <i>p</i> < 0.001), erythema (96.1% vs. 12.2%; <i>p</i> < 0.001), dry desquamation (50% vs. 3.9%; <i>p</i> < 0.001), and moist desquamation (18.4% vs. 0.6%; <i>p</i> < 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. <b><i>Conclusion:</i></b> The boron-based gel has a significant preventive effect on several categories of RD which might be used by clinicians in breast cancer.

The Use of Hydrogel-Based Materials for Radioprotection

“…Mechanistically, the authors speculated that this protective activity may have been mediated by the thermal degradation, pro-regenerative, and antioxidant effects of boron. Another randomized trial [ 65 ] enrolling 257 patients also demonstrated the ability of boron-based hydrogels to prevent most forms of radiation dermatitis in females undergoing radiotherapy to treat breast cancer, alleviating conditions including dermatitis, erythema, dry desquamation, and moist desquamation. Other studies have demonstrated the preventative or therapeutic effects of HA gels, film-forming silica gel, and etc.…”