CompletedPhase 2

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

Egypt132 participantsStarted 2023-01-24

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexFEMALE

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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

What they're measuring

Incidence of development of radiation induced dermatitis

Timeframe: 6 weeks

Trial details

NCT IDNCT05693597

SponsorGerman University in Cairo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-20

View on ClinicalTrials.gov More Radiation Dermatitis trials