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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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00438659
First received: February 20, 2007
Last updated: September 20, 2011
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Dermatologic Complications
Radiation Toxicity
Skin Reactions Secondary to Radiation Therapy
 Drug: mometasone furoate
Other: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum grade of radiation dermatitis as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of severe (grade ≥ 3) radiation dermatitis [ Designated as safety issue: Yes ]
  • Time to onset of severe radiation dermatitis [ Designated as safety issue: Yes ]
  • Duration of severe radiation dermatitis [ Designated as safety issue: Yes ]
  • Overall quality of life (QOL) as measured by Linear Analogue Self-Assessment (LASA) [ Designated as safety issue: No ]
  • QOL domains as measured by LASA [ Designated as safety issue: No ]
  • Skin toxicity as measured by Skindex-16 [ Designated as safety issue: Yes ]
  • Skin toxicity as measured by the Skin Toxicity Assessment Tool [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and assessed clinically by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 148
Study Start Date: August 2007
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients apply mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
 Drug: mometasone furoate
Applied to treatment area
Placebo Comparator: Arm II
Patients apply an identical-appearing placebo cream to the treatment area as in arm I.
 Other: placebo
Applied to treatment area

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438659

  Show 189 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Investigators
Study Chair: Robert C. Miller, MD Mayo Clinic
Investigator: Patricia Griffin, MD Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Investigator: James A. Martenson, MD Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Charles L. Loprinzi, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00438659     History of Changes
Other Study ID Numbers: CDR0000530309, NCCTG-N06C4
Study First Received: February 20, 2007
Last Updated: September 20, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Dermatitis
Radiodermatitis
Radiation Injuries
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Wounds and Injuries
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013