Breast Cancer Clinical Trial

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

Summary

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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
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 is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

176

Study ID:

NCT00438659

Recruitment Status:

Completed

Sponsor:

North Central Cancer Treatment Group

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There are 144 Locations for this study

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Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
St. Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Eureka Community Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline Illinois, 61265, United States

Moline Illinois, 61265, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
OSF St. Francis Medical Center
Peoria Illinois, 61615, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Valley Cancer Center
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States

Bettendorf Iowa, 52722, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City Iowa, 50401, United States
McCreery Cancer Center at Ottumwa Regional
Ottumwa Iowa, 52501, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Hickman Cancer Center at Bixby Medical Center
Adrian Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Hospital
Jackson Michigan, 49201, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville Michigan, 48144, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48912, United States
Community Cancer Center of Monroe
Monroe Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe Michigan, 48162, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw Michigan, 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph Michigan, 49085, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States

Alexandria Minnesota, 56308, United States
MeritCare Bemidji
Bemidji Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth Minnesota, 55805, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States

Fergus Falls Minnesota, 56537, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Lichfield Minnesota, 55355, United States
Immanuel St. Joseph's
Mankato Minnesota, 56002, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Coborn Cancer Center
Saint Cloud Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
HealthEast Cancer Care at St. Joseph's Hospital
St Paul Minnesota, 55102, United States
CentraCare Clinic - River Campus
St. Cloud Minnesota, 56303, United States
Park Nicollet Cancer Center
St. Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
St. Paul Minnesota, 55101, United States
United Hospital
St. Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury Minnesota, 55125, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
Saint Louis Missouri, 63141, United States
Missouri Baptist Cancer Center
St. Louis Missouri, 63131, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States

Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck North Dakota, 58502, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Broadway
Fargo North Dakota, 58122, United States
Mary Rutan Hospital
Bellefontaine Ohio, 43311, United States
Wood County Oncology Center
Bowling Green Ohio, 43402, United States
Adena Regional Medical Center
Chillicothe Ohio, 45601, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
CCOP - Columbus
Columbus Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus Ohio, 43215, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus Ohio, 43228, United States
Grady Memorial Hospital
Delaware Ohio, 43015, United States
Fremont Memorial Hospital
Fremont Ohio, 43420, United States
Fairfield Medical Center
Lancaster Ohio, 43130, United States
Lima Memorial Hospital
Lima Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta Ohio, 45750, United States
Northwest Ohio Oncology Center
Maumee Ohio, 43537, United States
St. Luke's Hospital
Maumee Ohio, 43537, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark Ohio, 43055, United States
St. Charles Mercy Hospital
Oregon Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon Ohio, 43616, United States
Firelands Regional Medical Center
Sandusky Ohio, 44870, United States
North Coast Cancer Care, Incorporated
Sandusky Ohio, 44870, United States
Mercy Medical Center
Springfield Ohio, 45504, United States
Community Hospital of Springfield and Clark County
Springfield Ohio, 45505, United States
Flower Hospital Cancer Center
Sylvania Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin Ohio, 44883, United States
Toledo Hospital
Toledo Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43617, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo Ohio, 43623, United States
Fulton County Health Center
Wauseon Ohio, 43567, United States
Mount Carmel St. Ann's Cancer Center
Westerville Ohio, 43081, United States
Genesis - Good Samaritan Hospital
Zanesville Ohio, 43701, United States
LaFortune Cancer Center at St. John Medical Center
Tulsa Oklahoma, 74104, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma, 74136, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Fredericksburg Oncology, Incorporated
Fredericksburg Virginia, 22401, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse Wisconsin, 54601, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

176

Study ID:

NCT00438659

Recruitment Status:

Completed

Sponsor:


North Central Cancer Treatment Group

How clear is this clinincal trial information?

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