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

Objective: The present study aimed to evaluate the effectiveness of Nigella sativa L (N. saliva) extract on preventing the incidence of acute radiation dermatitis (ARD) in breast cancer patients. Methods: 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. Results: Patients who were treated with the N. saliva 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. saliva 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. saliva 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. saliva gel group at week 3 (2.5 +/- 0.5 vs. 1.2 +/- 0.3, p < 0.05). Nonetheless, the application of N. saliva gel had no significant effect on the SRQOL of patients at any week. Conclusion: N. saliva extract significantly decreases the severity of ARD and delays the onset of moist desquamation in breast cancer patients.