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

North Central Cancer Treatment Group

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Radiation Toxicity; Dermatologic Complications; Skin Reactions Secondary to Radiation Therapy

Treatments: Drug: mometasone furoate; Other: placebo

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00438659

NCI-2012-02708 (Registry Identifier)

CDR0000530309 (Registry Identifier)

NCCTG-N06C4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups, including a placebo group

Mometasone

Experimental group

Description:

Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.

Treatment:

Drug: mometasone furoate

Placebo

Placebo Comparator group

Description:

Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.

Treatment:

Other: placebo