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

Complement Ther Med. 2019 Dec:47:102205. doi: 10.1016/j.ctim.2019.102205. Epub 2019 Oct 3.


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 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. 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.

Keywords: Acute radiation dermatitis; Black cumin; Breast cancer; Nigella sativa L.; Prevention; Radiotherapy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Administration, Topical
  • Adult
  • Breast Neoplasms / radiotherapy*
  • Double-Blind Method
  • Female
  • Humans
  • Middle Aged
  • Nigella sativa / chemistry*
  • Phytotherapy / methods*
  • Radiodermatitis / prevention & control*
  • Radiotherapy / adverse effects*