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Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy

Phase 3
18 Years
Not Enrolling
Breast Cancer, Dermatologic Complications, Radiation Toxicity, Skin Reactions Secondary to Radiation Therapy

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Trial Information

Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy



- 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.


- 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

- 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.

Inclusion Criteria


- 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

- 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


- 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


- 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

- Cortaid®

- Cortizone 10®

- Tucks®

- Preparation H®

- No other concurrent topical agents (e.g., lotions, aloe vera) to radiotherapy field
during study treatment

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Maximum grade of radiation dermatitis as measured by NCI CTCAE v3.0

Safety Issue:


Principal Investigator

Robert C. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Dermatologic Complications
  • Radiation Toxicity
  • Skin Reactions Secondary to Radiation Therapy
  • 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
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Dermatitis
  • Radiodermatitis
  • Radiation Injuries



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