Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32
NCT ID: NCT01286233
Last Updated: 2015-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
394 participants
OBSERVATIONAL
2011-07-31
2016-09-30
Brief Summary
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PURPOSE: This research study is studying biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.
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Detailed Description
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* To prepare, separate into components, and store the blood specimens at the NSABP Serum Bank at Baylor College of Medicine Breast Center for future DNA, RNA, and plasma analysis, and to analyze specific proinflammatory cytokines, genetic polymorphisms, and RNA expression arrays in collaborating laboratories at University of California, Los Angeles (UCLA).
* To examine the association between markers of inflammation and symptoms of fatigue among patients with and without exposure to metformin hydrochloride.
* To examine the relationship between single nucleotide polymorphism (SNPs) in the promoter regions of IL-1 and IL-6 and symptoms of fatigue with and without exposure to metformin hydrochloride.
* To examine RNA expression profiles in relationship to fatigue and compare the pattern of expression in patients with and without exposure to metformin hydrochloride.
* To determine the biological and behavioral predictors of fatigue in breast cancer patients in the five years post-randomization.
* To determine whether metformin is associated with reductions in inflammatory markers and corresponding decreases in fatigue. (Exploratory)
OUTLINE: This is a multicenter study.
Patients' serum and plasma, collected at baseline and at 6, 12, and 24 months after NCIC CTG MA.32 randomization, are analyzed for inflammatory markers, DNA polymorphisms, and RNA expression arrays by ELISA, TaqMan PCR, and RT-PCR.
Patients complete the Fatigue Symptom Inventory (symptoms associated with fatigue, sleep disturbance, depression, and endocrine therapy) at baseline and periodically during study.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1: Metformin
850 mg orally twice a day for 5 years
Metformin
Group 2: Placebo
One caplet orally twice a day for 5 years
Placebo
Interventions
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Metformin
Placebo
Eligibility Criteria
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Inclusion Criteria
* The patient must be female.
* The patient must reside in the United States or Canada.
* The patient must be English-speaking.
* The patient must be eligible for randomization in the MA.32 treatment trial. (Participation in the MA.32 QOL study is permitted but not required.)
* The patient must not have started taking MA.32 study therapy.
* The patient must have completed primary breast radiation therapy at least two weeks prior to enrollment in MA.32.F.
Exclusion Criteria
* Currently receiving radiation therapy or additional radiation therapy is planned for initiation after starting MA.32 study therapy.
18 Years
74 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NSABP Foundation Inc
NETWORK
Responsible Party
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Principal Investigators
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Norman Wolmark, MD
Role: PRINCIPAL_INVESTIGATOR
NSABP Foundation Inc
Locations
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Kaiser Permanente Medical Center - Anaheim/Orange County
Anaheim, California, United States
Kaiser Permanente - Deer Valley
Antioch, California, United States
Kaiser Permanente Medical Center - Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente Medical Center - Bellflower
Bellflower, California, United States
Kaiser Permanente Medical Center - Fontana
Fontana, California, United States
Kaiser Permanente - Fremont
Fremont, California, United States
Kaiser Permanente Medical Center - Harbor City
Harbor City, California, United States
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States
Kaiser Permanente - Irvine
Irvine, California, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
Kaiser Foundation Hospital - West Los Angeles
Los Angeles, California, United States
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States
Kaiser Permanente - Ontario Vineyard Medical Offices and Ambulatory SurgiCenter
Ontario, California, United States
Kaiser Permanente Medical Group
Panorama City, California, United States
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States
Kaiser Permanente Medical Center - Riverside
Riverside, California, United States
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States
Kaiser Permanente Health Care
San Marcos, California, United States
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States
Kaiser Permanente Medical Center - Vacaville
Vacaville, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States
Kaiser Permanente Medical Cener - Woodland Hills
Woodland Hills, California, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Kaiser Permanente - Moanalua Medical Center and Clinic
Honolulu, Hawaii, United States
St. Joseph Regional Medical Center
Lewiston, Idaho, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Illinois CancerCare - Canton
Canton, Illinois, United States
Illinois CancerCare - Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Resurrection Medical Center
Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Illinois CancerCare - Eureka
Eureka, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States
Illinois CancerCare - Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare - Macomb
Macomb, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States
Moline, Illinois, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, United States
OSF Holy Family Medical Center
Monmouth, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Illinois CancerCare - Pekin
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare - Peru
Peru, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Illinois CancerCare - Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Central Dupage Cancer Center
Warrenville, Illinois, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States
Bettendorf, Iowa, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 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
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, 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
Cancer Center of Kansas, PA - Wichita
Wichita, 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 - Winfield
Winfield, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
York Hospital's Oncology Treatment Center
York Village, Maine, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, United States
Mercy General Health Partners
Muskegon, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
St. Joseph's Medical Center
Brainerd, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States
CCOP - 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
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
Midwest Hematology Oncology Group, Incorporated
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Immanuel Medical Center
Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States
Lakeside Hospital
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Lakes Region General Hospital
Laconia, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
High Point Regional Hospital
High Point, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Dakota Cancer Institute at Dakota Clinic - South University
Fargo, North Dakota, United States
Trinity CancerCare Center
Minot, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Willamette Falls Hospital
Oregon City, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Kaiser Permanente Health Care - Portland
Portland, Oregon, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Cancer Center at Phoenixville Hospital
Phoenixville, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Chester County Hospital
West Chester, Pennsylvania, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
AnMed Cancer Center
Anderson, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Doctor's Hospital of Laredo
Laredo, Texas, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Overlake Cancer Center at Overlake Hospital Medical Center
Bellevue, Washington, United States
Providence Centralia Hospital
Centralia, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
St. Francis Hospital
Federal Way, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States
Good Samaritan Cancer Center
Puyallup, Washington, United States
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States
Allenmore Hospital
Tacoma, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States
St. Clare Hospital
Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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NSABP-NCIC-CTG-MA.32.F
Identifier Type: -
Identifier Source: secondary_id
NSABP MA.32.F
Identifier Type: -
Identifier Source: org_study_id
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