Effectiveness and safety of 5% gel of extract of Nigella sativa L. to prevent radio-dermatitis in breast cancer patients

The aim of the study is to evaluate the efficacy and safety of Nigella sativa L. extract gel in the prevention of acute radiodermatitis in the breast cancer patients.

This study is a 2-arm, double-blinded, randomized clinical trial, designed to evaluate the efficacy and safety of Nigella sativa L. extract gel and placebo in breast cancer patients undergoing radiotherapy to the breast (breast conservation surgery) or chest wall (postmastectomy).

ٍEligible patients receiving radiation therapy will be recruited from Imam Khomeini Hospitals affiliated to Mazums. The patients will be received either 45 Gy in 20 fractions or 50 Gy in 25 fractions. The skin type of patients will be determined with Fitzpatrick skin type scale before the use of topical products and skin care procedures will be taught on the basis of the MASCC Skin Toxicity Study Group's Guide. The use of topical products is twice daily in radiotherapy period. Patients, clinical caregiver, outcome evaluator, and researcher have no information about the patients ' treatment group.

The women aged more than 18 years with a confirmed histological diagnosis of ductal or lobular breast carcinoma, who received adjuvant radiotherapy after breast surgery, will be included in this study.

Patients will be randomly assigned into two groups of gel 5% of Nigella sativa L. extracts and placebo gel.

Dermatologic reactions and pain were evaluated weekly during the radiotherapy period, and the results were based on Radiation Therapy Oncology Group and National Cancer Institute criteria: Common Terminology Criteria for Adverse Events v5.0 for skin reactions and numerical scaling scale for pain will be recorded. Also, the patients' quality of life will be evaluated based on the Dermatology Life Quality Index Questionnaire biweekly.

Patients will be treated with 5% Nigella sativa gel and placebo gel using the blocking method. The generation of random numbers is done with Random allocation software, and 60 samples will be assigned in 6 blocks of 10. All products used in the study are completely identical in terms of appearance and packaging, and their content will be characterized by a four-digit code.

Since all the products used in the study are completely identical in terms of appearance and packaging and their content is characterized by a four-digit code, patients do not have any information about their treatment group. Also, the patient's treatment group is determined randomly, according to the previously defined coding. Only the secretary of radiotherapy ward who offers the product to the patients knows the treatment groups of the patients. Clinical caregiver (physician), researcher and evaluator of the outcome (researcher) have no information on the treatment group of patients.