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

Phase 3

Completed

• Conditions: Breast Cancer; Radiation Toxicity; Skin Reactions Secondary to Radiation Therapy; Dermatologic Complications
• Interventions: Other: placebo; Drug: mometasone furoate

• Registration Number: NCT00438659
• Lead Sponsor: North Central Cancer Treatment Group

Brief 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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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 Timeline

• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-22
• Study Start: 2007-08
• Primary Completion: 2010-01
• Study Completion: 2014-06
• Results First Submitted: 2014-06-12
• Results First Submitted QC: 2015-02-11
• Results First Posted: 2015-02-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.
Mometasone	mometasone furoate	Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.

Primary Outcome Measures

Name	Time	Method
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.	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).

Secondary Outcome Measures

Name	Time	Method
Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)	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	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	During Radiation Treatment, up to a maximum of 9 weeks.
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).	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)
Incidence of Severe ( Grade >=3) Radiation Dermatitis	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	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).	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.	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.

Trial Locations

Locations (184)

Rush-Copley Cancer Care Center; 🇺🇸 Aurora, Illinois, United States

St. Joseph Medical Center; 🇺🇸 Bloomington, Illinois, United States

Graham Hospital; 🇺🇸 Canton, Illinois, United States

Memorial Hospital; 🇺🇸 Carthage, Illinois, United States

Eureka Community Hospital; 🇺🇸 Eureka, Illinois, United States

Galesburg Clinic, PC; 🇺🇸 Galesburg, Illinois, United States

Galesburg Cottage Hospital; 🇺🇸 Galesburg, Illinois, United States

InterCommunity Cancer Center of Western Illinois; 🇺🇸 Galesburg, Illinois, United States

Mason District Hospital; 🇺🇸 Havana, Illinois, United States

Hopedale Medical Complex; 🇺🇸 Hopedale, Illinois, United States

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