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
- Conditions
- Breast CancerRadiation ToxicitySkin Reactions Secondary to Radiation TherapyDermatologic Complications
- Interventions
- Other: placebo
- Registration Number
- NCT00438659
- Lead Sponsor
- North Central Cancer Treatment Group
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm I. Mometasone mometasone furoate Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
- Primary Outcome Measures
Name Time Method Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. 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).
- Secondary Outcome Measures
Name Time Method Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) 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).
QOL Domains as Measured by LASA 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.
Adverse Events Assessed Clinically by NCI CTCAE v3.0 During Radiation Treatment, up to a maximum of 9 weeks. Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). 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)
Incidence of Severe ( Grade >=3) Radiation Dermatitis 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.
Skin Toxicity as Measured by the Skin Toxicity Assessment Tool 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.
Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). 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).
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. 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.
Trial Locations
- Locations (184)
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Foote Hospital
🇺🇸Jackson, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Mercy Memorial Hospital - Monroe
🇺🇸Monroe, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Immanuel St. Joseph's
🇺🇸Mankato, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
HealthEast Cancer Care at St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸St. Louis Park, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Arch Medical Services, Incorporated at Center for Cancer Care and Research
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸St. Louis, Missouri, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
McCreery Cancer Center at Ottumwa Regional
🇺🇸Ottumwa, Iowa, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
LaFortune Cancer Center at St. John Medical Center
🇺🇸Tulsa, Oklahoma, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Franciscan Skemp Healthcare - La Crosse Campus
🇺🇸La Crosse, Wisconsin, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Fredericksburg Oncology, Incorporated
🇺🇸Fredericksburg, Virginia, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
🇺🇸Moline, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States