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”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control

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.

Intervention(s) in this Clinical Trial

• Drug: mometasone furoate
  • Applied to treatment area
• Other: placebo
  • Applied to treatment area

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm I
  • Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
• Placebo Comparator: Arm II
  • Patients apply an identical-appearing placebo cream to the treatment area as in arm I.

Primary Measures

• Maximum grade of radiation dermatitis as measured by NCI CTCAE v3.0
  • Safety Issue?: Yes

Secondary Measures

• Incidence of severe (grade ≥ 3) radiation dermatitis
  • Safety Issue?: Yes
• Time to onset of severe radiation dermatitis
  • Safety Issue?: Yes
• Duration of severe radiation dermatitis
  • Safety Issue?: Yes
• Overall quality of life (QOL) as measured by Linear Analogue Self-Assessment (LASA)
  • Safety Issue?: No
• QOL domains as measured by LASA
  • Safety Issue?: No
• Skin toxicity as measured by Skindex-16
  • Safety Issue?: Yes
• Skin toxicity as measured by the Skin Toxicity Assessment Tool
  • Safety Issue?: Yes
• Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and assessed clinically by NCI CTCAE v3.0
  • Safety Issue?: Yes

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of primary invasive breast cancer or ductal carcinoma in situ
• Planning to undergo ≥ 5 weeks of continuous definitive or adjuvant external-beam radiotherapy to 1 of the following sites:
• Whole breast (as part of breast-conservation therapy)
• Chest wall (as part of post-mastectomy irradiation)
• Treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary) allowed
• Must meet the following criteria for planned radiotherapy:
• Planned total radiation dose ≥ 5,000 Gy and daily radiation dose between 1.75 and 2.12 Gy
• No planned split-course radiotherapy
• No partial breast treatment, defined as treatment of < 75% of the breast parenchyma
• Intensity-modulated radiotherapy planning and delivery, conventional radiotherapy, or 3-dimensional radiotherapy techniques allowed
• Must be entered on study within 7 days prior to beginning radiotherapy
• Must start study drug prior to receiving the third radiotherapy fraction
• No preexisting skin breakdown within the planned radiotherapy field at the time of study entry
• No bilateral breast cancer treatment
• No inflammatory carcinoma of the breast
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Male or female
• Menopausal status not specified
• ECOG performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Able to complete questionnaires independently or with assistance
• No known allergy or hypersensitivity to mometasone furoate (Elocon® or generic cream), imidazolidinyl urea, or formaldehyde

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radiotherapy to the planned radiotherapy treatment area
• No concurrent or planned leukotriene inhibitors, including the following:
• Zafirleukast
• Monteleukast
• Zileuton
• 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:
• Cortaid®
• Cortizone 10®
• Tucks®
• Preparation H®
• No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field during study treatment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: North Central Cancer Treatment Group

Overall Clinical Trial Officials and Contacts

Robert C. Miller, MD Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00438659

Study ID Number: CDR0000530309

ClinicalTrials.gov Identifier: NCT00438659

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database