Nigella sativa L. for prevention of acute radiation dermatitis in breast cancer: A randomized, double-blind, placebo-controlled, clinical trial. (December 2019)

• Record Type: Journal Article
• Authors: Rafati, Mohammadreza; Ghasemi, Arash; Saeedi, Majid; Habibi, Emran; Salehifar, Ebrahim; Mosazadeh, Mahmood; Maham, Monireh
• Is Part Of: Complementary therapies in medicine. Volume 47(2019)
• Publication Date: 2019-12
• Subjects: N. sativa Nigella sativa L -- ARD acute radiation dermatitis -- RT radiotherapy -- TQ thymoquinone -- TCs topical corticosteroids -- HPLC high-performance liquid chromatography -- MASCC Multinational Association of Supportive Care in Cancer -- RTOG/EORTC Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer -- DLQI Dermatology Life Quality Index -- SPSS statistical package for the social sciences; Nigella sativa L. -- Black cumin -- Radiotherapy -- Acute radiation dermatitis -- Prevention -- Breast cancer; Alternative medicine -- Periodicals; Complementary Therapies -- Periodicals; Médecines parallèles -- Périodiques; Thérapeutique -- Périodiques; Alternative medicine; Electronic journals; Periodicals; 615.5
• DOI: 10.1016/j.ctim.2019.102205
• Languages: English
• ISSNs: 0965-2299

Abstract

Highlights: Acute radiation dermatitis (ARD) is the most frequently reported adverse effect of the breast radiotherapy. This study aimed to investigate Nigella sativa L. ( N. sativa ) 5% gel effectiveness in preventing ARD in breast cancer patients. The preventive use of the N. sativa gel significantly decreased and delayed the incidence of ARD and related symptoms. Abstract: Objective: 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. Methods: Sixty-two breast cancer patients undergoing radiotherapy (RT) were randomly assigned to receive N. 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. 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. Conclusion: N. sativa extract significantly decreases the severity of ARD and delays the onset of moist desquamation in breast cancer patients.