NCT02556632

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

Effectiveness of Prophylactic Topical Agents for Radiation Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Gary Morrow · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To investigate the effectiveness of Curcumin gel (curcumin-based gel) or HPR Plus™ in reducing radiation dermatitis in breast cancer patients.

Conditions

• Breast Carcinoma
• Pain
• Radiation-Induced Dermatitis
• Stage 0 Breast Cancer

Interventions

Type	Name	Description
DRUG	Curcumin-based Gel	Applied topically
PROCEDURE	Dermatologic Complications Management	Apply HPR Plus topically
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo	Apply placebo gel topically
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2015-10-13
• Primary completion: 2016-09-30
• Completion: 2016-09-30
• First posted: 2015-09-22
• Last updated: 2017-11-06
• Results posted: 2017-11-06

Locations

6 sites across 1 country: United States