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 - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00438659

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 III

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Mometasone furoate

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:

Miller RC, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Stoffel TJ, Haselow RE, Schaefer PL, Bearden JD 3rd, Atherton PJ, Loprinzi CL, Martenson JA. Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase III Double-Blind, Randomized Trial from the North Central Cancer Treatment Group N06C4. Int J Radiat Oncol Biol Phys. 2010 Aug 26; [Epub ahead of print]

Neben-Wittich MA, Atherton PJ, Schwartz DJ, Sloan JA, Griffin PC, Deming RL, Anders JC, Loprinzi CL, Burger KN, Martenson JA, Miller RC. Comparison of Provider-Assessed and Patient-Reported Outcome Measures of Acute Skin Toxicity During a Phase III Trial of Mometasone Cream Versus Placebo During Breast Radiotherapy: The North Central Cancer Treatment Group (N06C4). Int J Radiat Oncol Biol Phys. 2010 Sep 30; [Epub ahead of print]

Atherton PJ, Burger KN, Loprinzi CL, Neben Wittich MA, Miller RC, Jatoi A, Sloan JA. Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer. 2011 Sep 16; [Epub ahead of print]

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 February 12, 2012