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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Central Cancer Treatment Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Mometasone Furoate

Criteria

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