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

NCT02556632 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2017-11-06

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gary Morrow

    lead OTHER

Principal Investigators

  • Gary Morrow · University of Rochester NCORP Research Base

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02556632 on ClinicalTrials.gov