Fikrettin Sahin1,2, Mohammad Bagher Pirouzpanah3, Hossein Bijanpour3, Mohammad Mohammadzadeh4, Reza Eghdam Zamiri4, Amir Ghasemi Jangjoo4, Behnam Nasiri5, Hojjatollah Saboori5, Ayşegül Doğan2, Selami Demirci6, Erhan Ayşan7, Ahmet Çağrı Büke8, Ali Reza Naseri4, Seyed Kazem Shakouri1, Dawood Aghamohammadi1, Mostafa Alizade-Harakiyan4, Farshad Seyed Nejad1,4,5. 1. Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. 2. Department of Genetics and Bioengineering, Faculty of Engineering, Yeditepe University, Istanbul, Turkey. 3. Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 4. Department of Radiation Oncology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. 5. Department of Radiation Oncology, Tabriz International Hospital, Tabriz, Iran. 6. Cellular and Molecular Therapeutics Branch, National Heart Lung and Blood Institutes and National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA. 7. Faculty of Medicine, Department of General Surgery, Yeditepe University, Istanbul, Turkey. 8. Department of Infectious Diseases, Yeditepe University Hospital, Yeditepe University, Istanbul, Turkey.
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.
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.