drugset / Trial / NCT05285943

Use of Topical Olive Oil Cream for Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients

NCT05285943

Phase 4 Completed 132 enrolled Cairo University
RandomizedParallel-groupDouble-blindPrevention

Summary

This study aims to compare the prophylactic effect of topical betamethasone valerate cream and topical olive oil cream in the prevention of acute radiation dermatitis (ARD) in breast cancer patients treated with radiation. Betamethasone valerate, olive oil cream and the base cream will be compared in a randomized trial to evaluate and compare the development and degree of ARD grading according to Radiation Toxicity Grading (RTOG) skin toxicity score, percentage of patients with the maximum observed ARD grade for each arm of the study, percentage of patients with moist desquamation for each arm of the study, percentage of radiodermatitis-free patients at end of therapy (EOT=time point specifically at end of 2 weeks post radiation therapy). In addition, the patients' quality of life will be evaluated using Dermatology Life Quality Index (DLQI).

Timeline

Start
2021-11-04
Primary completion
2024-01-31
Completion
2024-01-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Olive oil Other / unclassified Topical
Comparator betamethasone valerate Small molecule 0.1 % Topical

Indications