Status:
COMPLETED
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
Lead Sponsor:
North Central Cancer Treatment Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Dermatologic Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- Eastern Cooperative Oncology Group (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
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00438659
Start Date
August 1 2007
End Date
June 1 2014
Last Update
August 1 2016
Active Locations (189)
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1
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
2
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
3
Graham Hospital
Canton, Illinois, United States, 61520
4
Memorial Hospital
Carthage, Illinois, United States, 62321