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:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT00438659
First received: February 20, 2007
Last updated: February 11, 2015
Last verified: February 2015

February 20, 2007
February 11, 2015
August 2007
January 2010   (final data collection date for primary outcome measure)
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ] [ Designated as safety issue: No ]
Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE).
Maximum grade of radiation dermatitis as measured by NCI CTCAE v3.0
Complete list of historical versions of study NCT00438659 on ClinicalTrials.gov Archive Site
  • Incidence of Severe ( Grade >=3) Radiation Dermatitis [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ] [ Designated as safety issue: No ]
    To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.
  • Skin Toxicity as Measured by the Skin Toxicity Assessment Tool [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ] [ Designated as safety issue: No ]
    Mean of the Maximum Patient Reported Skin Toxicity Assessment Tool (STAT) per patient on a 0 to 5 scale during radiation treatment. Lower scores indicate less toxicity.
  • Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ] [ Designated as safety issue: No ]
    Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity).
  • Duration of Severe (Grade ≥ 3) Radiation Dermatitis as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. This Analysis Was Not Completed Due to Too Little Incidence of the Dermatitis. [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ] [ Designated as safety issue: No ]
    To compare time to onset and duration of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. This analysis was not completed due to too little incidence of the dermatitis.
  • Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ] [ Designated as safety issue: No ]
    Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL).
  • QOL Domains as Measured by LASA [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ] [ Designated as safety issue: No ]
    Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale.
  • Adverse Events Assessed Clinically by NCI CTCAE v3.0 [ Time Frame: During Radiation Treatment, up to a maximum of 9 weeks. ] [ Designated as safety issue: No ]
  • Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). [ Time Frame: During Radiation Treatment, up to a maximum of 11 weeks. ] [ Designated as safety issue: No ]
    Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)
  • Incidence of severe (grade ≥ 3) radiation dermatitis
  • Time to onset of severe radiation dermatitis
  • Duration of severe radiation dermatitis
  • Overall quality of life (QOL) as measured by Linear Analogue Self-Assessment (LASA)
  • QOL domains as measured by LASA
  • Skin toxicity as measured by Skindex-16
  • Skin toxicity as measured by the Skin Toxicity Assessment Tool
  • Frequency and severity of adverse events reported by the patient in the Symptom Experience Diary and assessed clinically by NCI CTCAE v3.0
Not Provided
Not Provided
 
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
Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Dermatologic Complications
  • Radiation Toxicity
  • Skin Reactions Secondary to Radiation Therapy
  • Drug: mometasone furoate
    Applied to treatment area
  • Other: placebo
    Applied to treatment area
  • Experimental: Mometasone
    Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
    Intervention: Drug: mometasone furoate
  • Placebo Comparator: Placebo
    Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.
    Intervention: Other: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
June 2014
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438659
NCCTG-N06C4, NCI-2012-02708, CDR0000530309
No
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Robert C. Miller, MD Mayo Clinic
Study Chair: Patricia Griffin, MD Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Study Chair: James A. Martenson, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP