- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438659
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Illinois
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Aurora, Illinois, United States, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, United States, 61701
- St. Joseph Medical Center
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Canton, Illinois, United States, 61520
- Graham Hospital
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Carthage, Illinois, United States, 62321
- Memorial Hospital
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Eureka, Illinois, United States, 61530
- Eureka Community Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, United States, 61401
- Galesburg Clinic, PC
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Galesburg, Illinois, United States, 61401
- InterCommunity Cancer Center of Western Illinois
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Havana, Illinois, United States, 62644
- Mason District Hospital
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Hopedale, Illinois, United States, 61747
- Hopedale Medical Complex
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Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Kewanee, Illinois, United States, 61443
- Kewanee Hospital
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Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
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Moline, Illinois, United States, 61265
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Moline, Illinois, United States, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Normal, Illinois, United States, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, United States, 61761
- Community Cancer Center
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Ottawa, Illinois, United States, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, United States, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, United States, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, United States, 61614
- Proctor Hospital
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Peoria, Illinois, United States, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, United States, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peoria, Illinois, United States, 61615-7827
- OSF St. Francis Medical Center
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Peru, Illinois, United States, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, United States, 61362
- St. Margaret's Hospital
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Spring Valley, Illinois, United States, 61362
- Valley Cancer Center
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Urbana, Illinois, United States, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
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Kokomo, Indiana, United States, 46904
- Howard Community Hospital
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La Porte, Indiana, United States, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Michigan City, Indiana, United States, 46360
- Saint Anthony Memorial Health Centers
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South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, United States, 46617
- Saint Joseph Regional Medical Center
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Iowa
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Ames, Iowa, United States, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, United States, 52722
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Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Associates
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Des Moines, Iowa, United States, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, United States, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, United States, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, United States, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, United States, 50307
- Mercy Capitol Hospital
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Mason City, Iowa, United States, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, United States, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, United States, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, United States, 51104
- Mercy Medical Center - Sioux City
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Kansas
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Chanute, Kansas, United States, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas, PA - El Dorado
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Kingman, Kansas, United States, 67068
- Cancer Center of Kansas, PA - Kingman
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Liberal, Kansas, United States, 67901
- Southwest Medical Center
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Newton, Kansas, United States, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, United States, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, United States, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, United States, 67042
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, United States, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, United States, 67214
- Wesley Medical Center
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Wichita, Kansas, United States, 67203
- Associates in Womens Health, PA - North Review
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Wichita, Kansas, United States, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, United States, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, United States, 67214
- CCOP - Wichita
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Wichita, Kansas, United States, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Winfield, Kansas, United States, 67156
- Cancer Center of Kansas, PA - Winfield
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Michigan
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Adrian, Michigan, United States, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, United States, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, United States, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, United States, 49201
- Foote Hospital
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Lambertville, Michigan, United States, 48144
- Haematology-Oncology Associates of Ohio and Michigan, PC
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Lansing, Michigan, United States, 48912-1811
- Sparrow Regional Cancer Center
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Monroe, Michigan, United States, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, United States, 48162
- Mercy Memorial Hospital - Monroe
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Saginaw, Michigan, United States, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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St. Joseph, Michigan, United States, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Warren, Michigan, United States, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, United States, 56308
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Bemidji, Minnesota, United States, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, United States, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Duluth, Minnesota, United States, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, United States, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
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Fergus Falls, Minnesota, United States, 56537
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Fridley, Minnesota, United States, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, United States, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, United States, 55355
- Meeker County Memorial Hospital
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Mankato, Minnesota, United States, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, United States, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, United States, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, United States, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, United States, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St Paul, Minnesota, United States, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
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St. Cloud, Minnesota, United States, 56303
- CentraCare Clinic - River Campus
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St. Louis Park, Minnesota, United States, 55416
- Park Nicollet Cancer Center
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St. Paul, Minnesota, United States, 55102
- United Hospital
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St. Paul, Minnesota, United States, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Woodbury, Minnesota, United States, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
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Missouri
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Saint Louis, Missouri, United States, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
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St. Louis, Missouri, United States, 63131
- Missouri Baptist Cancer Center
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, United States, 59101
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Billings, Montana, United States, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, United States, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, United States, 59107-7000
- Billings Clinic - Downtown
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Bozeman, Montana, United States, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, United States, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, United States, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, United States, 59405
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Great Falls, Montana, United States, 59405-5309
- Big Sky Oncology
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Helena, Montana, United States, 59601
- St. Peter's Hospital
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Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, United States, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, United States, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, United States, 59801
- Community Medical Center
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Missoula, Montana, United States, 59804
- Guardian Oncology and Center for Wellness
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Missoula, Montana, United States, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, United States, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Cancer Resource Center - Lincoln
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North Carolina
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Rutherfordton, North Carolina, United States, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, United States, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, United States, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, United States, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, United States, 58122
- MeritCare Broadway
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Ohio
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Bellefontaine, Ohio, United States, 43311
- Mary Rutan Hospital
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Bowling Green, Ohio, United States, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
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Columbus, Ohio, United States, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, United States, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, United States, 43215
- CCOP - Columbus
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Columbus, Ohio, United States, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, United States, 43228
- Doctors Hospital at Ohio Health
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Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
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Fremont, Ohio, United States, 43420
- Fremont Memorial Hospital
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Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
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Lima, Ohio, United States, 45804
- Lima Memorial Hospital
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Marietta, Ohio, United States, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, United States, 43537
- Northwest Ohio Oncology Center
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Maumee, Ohio, United States, 43537
- St. Luke's Hospital
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Newark, Ohio, United States, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, United States, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, United States, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, United States, 44870
- Firelands Regional Medical Center
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Sandusky, Ohio, United States, 44870
- North Coast Cancer Care, Incorporated
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Springfield, Ohio, United States, 45505
- Community Hospital of Springfield and Clark County
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Springfield, Ohio, United States, 45504
- Mercy Medical Center
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Sylvania, Ohio, United States, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, United States, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, United States, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, United States, 43606
- Toledo Hospital
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Toledo, Ohio, United States, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, United States, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, United States, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Wauseon, Ohio, United States, 43567
- Fulton County Health Center
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Westerville, Ohio, United States, 43081
- Mount Carmel St. Ann's Cancer Center
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Zanesville, Ohio, United States, 43701
- Genesis - Good Samaritan Hospital
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Tulsa, Oklahoma, United States, 74104
- LaFortune Cancer Center at St. John Medical Center
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South Carolina
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Anderson, South Carolina, United States, 29621
- AnMed Cancer Center
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, United States, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, United States, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, United States, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Fredericksburg, Virginia, United States, 22401
- Fredericksburg Oncology, Incorporated
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Wisconsin
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Green Bay, Wisconsin, United States, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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La Crosse, Wisconsin, United States, 54601
- Franciscan Skemp Healthcare - La Crosse Campus
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Marinette, Wisconsin, United States, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Wyoming
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Sheridan, Wyoming, United States, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Applied to treatment area
|
Placebo Comparator: Placebo
Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I.
|
Applied to treatment area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.
Time Frame: During Radiation Treatment, up to a maximum of 9 weeks.
|
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).
|
During Radiation Treatment, up to a maximum of 9 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Severe ( Grade >=3) Radiation Dermatitis
Time Frame: During Radiation Treatment, up to a maximum of 9 weeks.
|
To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms.
|
During Radiation Treatment, up to a maximum of 9 weeks.
|
Skin Toxicity as Measured by the Skin Toxicity Assessment Tool
Time Frame: During Radiation Treatment, up to a maximum of 9 weeks.
|
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.
|
During Radiation Treatment, up to a maximum of 9 weeks.
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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.
|
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).
|
During Radiation Treatment, up to a maximum of 11 weeks.
|
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.
|
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.
|
During Radiation Treatment, up to a maximum of 9 weeks.
|
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.
|
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).
|
During Radiation Treatment, up to a maximum of 11 weeks.
|
QOL Domains as Measured by LASA
Time Frame: During Radiation Treatment, up to a maximum of 11 weeks.
|
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.
|
During Radiation Treatment, up to a maximum of 11 weeks.
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Adverse Events Assessed Clinically by NCI CTCAE v3.0
Time Frame: During Radiation Treatment, up to a maximum of 9 weeks.
|
During Radiation Treatment, up to a maximum of 9 weeks.
|
|
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Time Frame: During Radiation Treatment, up to a maximum of 11 weeks.
|
Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better)
|
During Radiation Treatment, up to a maximum of 11 weeks.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: James A. Martenson, MD, Mayo Clinic
- Study Chair: Robert C. Miller, MD, Mayo Clinic
- Study Chair: Patricia Griffin, MD, Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Publications and helpful links
General Publications
- 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. 2012 Aug;20(8):1729-35. doi: 10.1007/s00520-011-1266-x. Epub 2011 Sep 16.
- 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. 2011 Apr 1;79(5):1460-6. doi: 10.1016/j.ijrobp.2010.01.031. Epub 2010 Aug 26.
- 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. 2011 Oct 1;81(2):397-402. doi: 10.1016/j.ijrobp.2010.05.065. Epub 2010 Oct 1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- male breast cancer
- stage II breast cancer
- stage IIIC breast cancer
- stage I breast cancer
- radiation toxicity
- breast cancer in situ
- ductal breast carcinoma in situ
- dermatologic complications
- skin reactions secondary to radiation therapy
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Wounds and Injuries
- Breast Diseases
- Radiation Injuries
- Carcinoma in Situ
- Breast Neoplasms
- Dermatitis
- Radiodermatitis
- Anti-Inflammatory Agents
- Dermatologic Agents
- Anti-Allergic Agents
- Mometasone Furoate
Other Study ID Numbers
- NCCTG-N06C4
- NCI-2012-02708 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- CDR0000530309 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on mometasone furoate
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Teva Pharmaceuticals USACompletedSeasonal Allergic Rhinitis
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Padagis LLCCompleted
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Eurofarma Laboratorios S.A.CompletedMild to Moderate Persistent Allergic RhinitisBrazil
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Massachusetts General HospitalMerck Sharp & Dohme LLC; Massachusetts Eye and Ear InfirmaryTerminatedNasal PolypsUnited States
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Montefiore Medical CenterWithdrawnRadiation DermatitisUnited States
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University of FloridaGlaxoSmithKline; Food and Drug Administration (FDA)CompletedHypersensitivityUnited States
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GlaxoSmithKlineCompleted
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Novartis PharmaceuticalsCompletedAsthmaGermany, Slovakia, Bulgaria, Canada, Poland, Korea, Republic of, Netherlands, Japan
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Novartis PharmaceuticalsCompletedMild AsthmaGermany, India, Korea, Republic of, Poland, South Africa, Estonia, Italy, Russian Federation, Thailand, Latvia, Lithuania, Colombia, Hungary, Peru, Philippines, Slovakia, Bulgaria, Vietnam, Japan, Malaysia, Chile, Sweden
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James J. Peters Veterans Affairs Medical CenterKessler Institute for RehabilitationUnknownSpinal Cord InjuryUnited States