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
|ClinicalTrials.gov Identifier: NCT00438659|
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : February 12, 2015
Last Update Posted : August 1, 2016
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 or disease||Intervention/treatment||Phase|
|Breast Cancer Dermatologic Complications Radiation Toxicity Skin Reactions Secondary to Radiation Therapy||Drug: mometasone furoate Other: placebo||Phase 3|
- Compare the efficacy of mometasone furoate vs placebo, in terms of decreased maximal severity of radiation dermatitis, in patients undergoing primary or adjuvant radiotherapy to the breast or chest wall for invasive breast cancer or ductal carcinoma in situ.
- Compare the incidence of severe (grade ≥ 3) radiation dermatitis in patients treated with these drugs.
- Compare the time to onset and duration of severe radiation dermatitis in these patients.
- Assess skin toxicity and quality of life of these patients.
- Assess the adverse event profile of mometasone furoate in these patients.
- Compare skin toxicity data, in terms of provider-completed and patient-reported assessments, of patients treated with these drugs.
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.
- Arm I: Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
- Arm II: Patients apply an identical-appearing placebo cream to the treatment area as in arm I.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||June 2014|
U.S. FDA Resources
Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
Drug: mometasone furoate
Applied to treatment area
Placebo Comparator: Placebo
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.
Applied to treatment area
- Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).
- Incidence of Severe ( Grade >=3) Radiation Dermatitis [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.
- Skin Toxicity as Measured by the Skin Toxicity Assessment Tool [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.
- Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ]Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).
- Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis. [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.
- Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ]Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).
- QOL Domains as Measured by LASA [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ]Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.
- Adverse Events Assessed Clinically by NCI CTCAE v3.0 [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ]
- Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ]Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438659
Show 189 Study Locations
|Study Chair:||Robert C. Miller, MD||Mayo Clinic|
|Study Chair:||Patricia Griffin, MD||Gibbs Regional Cancer Center at Spartanburg Regional Medical Center|
|Study Chair:||James A. Martenson, MD||Mayo Clinic|