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

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German University in Cairo

Criteria

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