CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 191 enrolled
Drug / intervention
Curcumin-based Gel +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02556632
NCT02556632Phase 2Completed
CompareCT.gov

Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis

Gary Morrow·interventional·Posted Sep 22, 2015·Updated Nov 6, 2017

In Brief

A Phase 2 clinical trial evaluating Curcumin-based Gel, Dermatologic Complications Management, and 3 other interventions for Breast Carcinoma and 3 related conditions. Completed, enrolled 191 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Carcinoma, Pain, Radiation-Induced Dermatitis, Stage 0 Breast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 22, 2015
Enrollment StartOct 13, 2015
Primary CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 10.8 years ago

Interventions

Curcumin-based Geldrug

Applied topically

Dermatologic Complications Managementprocedure

Apply HPR Plus topically

Laboratory Biomarker Analysisother

Correlative studies

Placeboother

Apply placebo gel topically

Questionnaire Administrationother

Ancillary studies