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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00438659 |
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.
Condition | Intervention | Phase |
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Breast Cancer Cancer-Related Problem/Condition |
Drug: mometasone furoate Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy |
Estimated Enrollment: | 148 |
Study Start Date: | August 2007 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
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Drug: mometasone furoate
Applied to treatment area
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Arm II: Placebo Comparator
Patients apply an identical-appearing placebo cream to the treatment area as in arm I.
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Drug: placebo
Applied to treatment area
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to radiation field (breast [post-lumpectomy] vs chest wall [post-mastectomy]), regional lymph nodes (treated vs not treated), and planned total radiation dose (including boost) (50-55 Gy vs > 55 Gy). Patients are randomized to 1 of 2 treatment arms.
Patients complete questionnaires and a symptom experience diary at baseline and periodically during study for quality of life, skin toxicity, and adverse event assessment.
After completion of radiotherapy, patients are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:
Chest wall (as part of post-mastectomy irradiation)
Must meet the following criteria for planned radiotherapy:
Must be entered on study within 7 days prior to beginning radiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent or planned leukotriene inhibitors, including the following:
No concurrent or planned use of any prescription or over-the-counter medications containing hydrocortisone or any other cortisone or steroid-containing preparations (systemic, local, or topical) including, but not limited to, the following creams or ointments:
Study Chair: | Robert C. Miller, MD | Mayo Clinic |
Investigator: | Patricia Griffin, MD | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center |
Investigator: | James A. Martenson, MD | Mayo Clinic |
Study ID Numbers: | CDR0000530309, NCCTG-N06C4 |
Study First Received: | February 20, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00438659 |
Health Authority: | United States: Federal Government |
dermatologic complications skin reactions secondary to radiation therapy radiation toxicity breast cancer in situ recurrent breast cancer stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer male breast cancer ductal breast carcinoma in situ stage IV breast cancer |
Skin Diseases Mometasone furoate Wounds and Injuries Disorders of Environmental Origin Breast Neoplasms Radiodermatitis Recurrence Carcinoma Carcinoma, Ductal Breast Neoplasms, Male |
Carcinoma in Situ Neoplasm Metastasis Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Adenocarcinoma Radiation Injuries Breast Diseases Neoplasms, Glandular and Epithelial Dermatitis |
Anti-Inflammatory Agents Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Therapeutic Uses Anti-Allergic Agents Neoplasms, Ductal, Lobular, and Medullary Pharmacologic Actions |