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.

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

Sahin F ，Pirouzpanah MB ，Bijanpour H ，Mohammadzadeh M ，Eghdam Zamiri R ，Ghasemi Jangjoo A ，Nasiri B ，Saboori H ，Doğan A ，Demirci S ，Ayşan E ，Çağrı Büke A ，Naseri AR ，Shakouri SK ，Aghamohammadi D ，Alizade-Harakiyan M ，Seyed Nejad F ... -  《-》

Nigella sativa L. for prevention of acute radiation dermatitis in breast cancer: A randomized, double-blind, placebo-controlled, clinical trial.

The present study aimed to evaluate the effectiveness of Nigella sativa L. (N. sativa) extract on preventing the incidence of acute radiation dermatitis (ARD) in breast cancer patients. Sixty-two breast cancer patients undergoing radiotherapy (RT) were randomly assigned to receiveN. sativa 5% gel or placebo. Patients were instructed to apply the medications twice daily during RT period. The severity of ARD, the incidence of moist desquamation, worst experienced pain, and skin-related quality of life (SRQOL) scores were assessed weekly during RT. Patients who were treated with the N. sativa gel developed ARD significantly less frequently compared to those who used the placebo (p < 0.05 for all weeks except week 2, p = 0.36). The incidence time of grade 2 and 3 of Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) toxicity was prolonged significantly with N. sativa gel as compared to placebo (35 vs. 29 days, p = 0.00 and 42 vs. 40 days, p = 0.01, respectively). Furthermore, the occurrence of moist desquamation was delayed in the N. sativa gel group compared with the placebo group (37 vs. 33 days, p = 0.01). The mean score of the worst pain that patients experienced in the placebo group was significantly higher than that of the N. sativa gel group at week 3 (2.5 ± 0.5 vs. 1.2 ± 0.3, p < 0.05). Nonetheless, the application of N. sativa gel had no significant effect on the SRQOL of patients at any week. N. sativa extract significantly decreases the severity of ARD and delays the onset of moist desquamation in breast cancer patients.

Rafati M ，Ghasemi A ，Saeedi M ，Habibi E ，Salehifar E ，Mosazadeh M ，Maham M ... -  《-》

Comparison of liposomal gel with and without addition of chamomile for prevention of radiation dermatitis in head and neck cancer patients: A randomized controlled trial.

Head and neck cancer patients frequently develop radiation dermatitis (RD) during radiotherapy. We compared liposomal gel with and without chamomile extract for the prevention and management of RD in head and neck cancer patients undergoing radiotherapy. Sixty participants undergoing radiotherapy for the first time for head and neck cancer were recruited in a double-blind randomized clinical trial. Primary outcomes were the occurrence of dry desquamation and the cumulative dose of ionizing radiation at the first occurrence of dry desquamation. Secondary outcomes were the occurrence of erythema, moist desquamation, global RD, and participant self-reported symptoms. Dry desquamation occurred in 76.9 % (95 % CI: 57.9, 89.0) of participants in the chamomile liposomal gel group and in 88.9 % (95 % CI: 71.9, 96.1) in the liposomal gel group (p = 0.43). The median cumulative dose of ionizing radiation when dry desquamation occurred was 48.0 Gy in the chamomile liposomal gel group and 40.0 Gy in the liposomal gel group. Fewer symptoms were reported in the chamomile liposomal gel group. No statistically significant differences in outcomes were found between the two groups, though the chamomile liposomal gel group presented with lower grades of RD than the liposomal gel group. In addition, when compared to the literature on other topical interventions to manage RD, our results show that chamomile liposomal gel has potential for better management and prevention of RD in this population, which should be further tested. This study provides crucial information to design future studies. Clinical Trials Registration (REBEC): RBR-92cts3.

Menêses AG ，Ferreira EB ，Vieira LAC ，Bontempo PSM ，Guerra ENS ，Ciol MA ，Reis PED ... -  《-》

Effects of Boron-Based Gel on Radiation-Induced Dermatitis in Breast Cancer: A Double-Blind, Placebo-Controlled Trial.

Aysan E ，Idiz UO ，Elmas L ，Saglam EK ，Akgun Z ，Yucel SB ... -  《-》

Retrospective study of radiotherapy-induced skin reactions in breast cancer patients: reduced incidence of moist desquamation with a hydroactive colloid gel versus dexpanthenol.

Dermatitis is a very frequent and distressing side effect of radiation therapy that may necessitate a treatment interruption when evolving towards more severe forms such as moist desquamation (MD). The aim of this study was to compare the efficacy of two topical agents, a dexpanthenol cream vs a hydroactive colloid gel combining absorbing and moisturising properties, in preventing MD in breast cancer patients. This retrospective study compared two successive groups of breast cancer patients undergoing radiotherapy after breast-sparing surgery between 2008 and 2012. A group of 267 patients applied a 5% dexpanthenol cream on the irradiated zone throughout the course of their radiotherapy. Another group of 216 patients applied first the dexpanthenol cream then replaced it by the hydroactive colloid gel after 11-14 days of radiotherapy. Radiation treatment (total dose, technique, and equipment) was the same for the two groups. The clinical outcomes were the occurrence and time to onset of moist desquamation. The overall incidence of MD was significantly lower in patients who applied the hydroactive colloid gel (16%) than in those who applied the dexpanthenol cream (32%, odds-ratio = 0.35). Also, MD occurred significantly later with the hydroactive colloid gel than with the dexpanthenol cream (hazard ratio = 0.39). Compared with the dexpanthenol cream, the hydroactive colloid gel significantly reduced the risk of developing MD in patients undergoing radiotherapy for breast cancer. These promising results warrant further research on the efficacy of hydroactive colloid gels in managing radiation dermatitis.

Censabella S ，Claes S ，Orlandini M ，Braekers R ，Thijs H ，Bulens P ... -  《-》