At a glance
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A Comparative Study Between Topical Betamethasone Cream or Topical Olive Oil Cream in Prophylaxis Against Acute Radiodermatitis in Breast Cancer Patients.
In Brief
A Phase 4 clinical trial evaluating Olive oil cream, Betamethasone Valerate Cream, and 1 other intervention for Radiodermatitis; Acute. Completed, enrolled 132 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Olive oil prepared in a base cream to be applied to irradiated areas.
Betamethasone valerate prepared in a base cream to be applied to irradiated areas.
The base cream used for preparation of both the betamethasone valerate cream and olive cream will be used as a placebo control to be applied to irradiated areas.