Evaluation of the Effect of Nigella Sativa for the Prophylaxis to Radiation Induced Dermatitis in Breast Cancer Patients

N.sativavsRID BreastCancerpt.

Radiation induced dermatitis (RID) is one of the leading adverse events of radiation therapy, and if occurred could alter the course of therapy. The main pathways of RID is inflammation and oxidative stress on local and systemic bases. Nigella sativa is an herbal medicine whose anti-inflammatory and antioxidant activities have been proven in several clinical trials. Thus, the aim of the present study is to evaluate the efficacy of Nigella sativa as a prophylactic method against the development of RID.

2023-01-24

2024-02-20

2024-02-20

Completed

Early phase I

132

Inclusion Criteria: * Histologically confirmed invasive, early stage breast carcinoma scheduled for adjuvant radiotherapy. * Women aged ≥18 years. Exclusion Criteria: * Prior exposure to radiotherapy * Patients with generalized skin disorder * Patients who failed to sign the written consent

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group I (control): Patients will not receive any prophylactic intervention, as there is no standard of care for prophylaxis to the radiation induced dermatitis (RID).\n\nGroup II (Topical intervention): Patients will receive Imtenan ® N. sativa oil apply 1.5 mls; twice daily; not sooner than 2 hours before and after radiation therapy; from day 1 of radiation therapy till the end.\n\nGroup III (Oral intervention): Patients will receive Baraka ® N. sativa gelatin capsules; 40mg/Kg/day; from day 1 of radiation therapy till the end', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 132, 'type': 'ACTUAL'}}

2024-02-23