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Mometasone Furoate in Preventing Radiation Dermatitis in Patients Undergoing Radiation Therapy to the Breast or Chest Wall for Invasive Breast Cancer or Ductal Carcinoma in Situ

NCT00438659 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2016-08-01

Study results available
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Summary

RATIONALE: Steroid therapy, such as mometasone furoate, may prevent radiation dermatitis caused by radiation therapy. It is not yet known whether mometasone furoate is more effective than a placebo in preventing radiation dermatitis.

PURPOSE: This randomized phase III trial is studying mometasone furoate to see how well it works compared to a placebo in preventing radiation dermatitis in patients undergoing radiation therapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.

Conditions

  • Breast Cancer
  • Dermatologic Complications
  • Radiation Toxicity
  • Skin Reactions Secondary to Radiation Therapy

Interventions

DRUG

mometasone furoate

Applied to treatment area

OTHER

placebo

Applied to treatment area

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • North Central Cancer Treatment Group

    lead NETWORK

Principal Investigators

  • Robert C. Miller, MD · Mayo Clinic

  • Patricia Griffin, MD · Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

  • James A. Martenson, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-01-31
Completion
2014-06-30

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 NCT00438659 on ClinicalTrials.gov