drugset / Trial / NCT02556632

Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer

NCT02556632 ↗

RandomizedParallel-groupTriple-blindSupportive care

Summary

This randomized pilot phase II trial studies and compares prophylactic topical agents in reducing radiation-induced dermatitis in patients with non-inflammatory breast cancer or breast cancer in situ. The prophylactic topical agents, such as curcumin-based gel or HPR Plus, may reduce the severity of the radiation-induced dermatitis by minimizing water loss and inflammation during radiation therapy.

Timeline

Start
2015-10-13
Primary completion
2016-09-30
Completion
2016-09-30

Outcome

Missed primary endpoint

registry analysis (other test); Arm I (Curcumin-based Gel) vs Arm II (HPR Plus) vs Arm III (Placebo Gel); p = 0.9306; ANOVA NCT02556632 ↗

registry analysis (other test); Arm I (Curcumin-based Gel) vs Arm II (HPR Plus) vs Arm III (Placebo Gel); p = 0.8048; Fisher Exact NCT02556632 ↗

registry analysis (other test); Arm I (Curcumin-based Gel) vs Arm II (HPR Plus) vs Arm III (Placebo Gel); p = 0.8591; ANOVA NCT02556632 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Curcumin Small molecule — Topical