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
Condition: Breast Cancer; Dermatologic Complications; Radiation Toxicity; Skin Reactions Secondary to Radiation Therapy
MeSH terms: Breast Neoplasms; Carcinoma in Situ; Dermatitis; Radiodermatitis
Intervention: mometasone furoate; placebo
Intervention description: Applied to treatment area; Applied to treatment area
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dermatologic complications; skin reactions secondary to radiation therapy; radiation toxicity; breast cancer in situ; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; male breast cancer; ductal breast carcinoma in situ; stage IV breast cancer

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.
    

Eligibility 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