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Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer


N/A
18 Years
74 Years
Open (Enrolling)
Female
Breast Cancer, Depression, Fatigue, Sleep Disorders

Thank you

Trial Information

Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer


OBJECTIVES:

- 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.

Inclusion Criteria


Inclusion Criteria

- The patient must have consented to participate and must have signed and dated an
appropriate IRB-approved consent form that conforms to federal and institutional
guidelines for the MA.32.F Study before being enrolled.

- 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

- MA.32 study therapy has been initiated.

- Currently receiving radiation therapy or additional radiation therapy is planned for
initiation after starting MA.32 study therapy.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Questionnaire scores from patient reported outcome battery regarding fatigue, stress, sleep, depression, and general quality of life

Outcome Time Frame:

Collected at baseline and 6, 12, 24, and 36 months from randomization

Safety Issue:

No

Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NSABP Foundation, Inc.

Authority:

Canada: Ethics Review Committee

Study ID:

NSABP MA.32.F

NCT ID:

NCT01286233

Start Date:

July 2011

Completion Date:

September 2016

Related Keywords:

  • Breast Cancer
  • Depression
  • Fatigue
  • Sleep Disorders
  • fatigue
  • sleep disorders
  • depression
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Fatigue
  • Sleep Disorders
  • Parasomnias

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - NorthwestTacoma, Washington  98405-0986
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Central Baptist HospitalLexington, Kentucky  40503
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Chester County HospitalWest Chester, Pennsylvania  19380
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Munson Medical CenterTraverse City, Michigan  49684
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Dakota Cancer Institute at Dakota Clinic - South UniversityFargo, North Dakota  58103-4940
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Front Range Cancer SpecialistsFort Collins, Colorado  80528
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Kaiser Permanente - FremontFremont, California  94538
Kaiser Permanente Medical Center - HaywardHayward, California  94545
Kaiser Permanente Medical Center - Redwood CityRedwood City, California  94063
Kaiser Permanente Medical Center - RichmondRichmond, California  94801
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
South Sacramento Kaiser-Permanente Medical CenterSacramento, California  95823
Kaiser Permanente Medical Office -Vandever Medical OfficeSan Diego, California  92120
Kaiser Permanente Medical Center - Santa TeresaSan Jose, California  95119
Kaiser Foundation Hospital - San RafaelSan Rafael, California  94903
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente Medical Facility - StocktonStockton, California  95210
Kaiser Permanente Medical Center - Walnut CreekWalnut Creek, California  94596
Poudre Valley HospitalFort Collins, Colorado  80524
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Bettendorf, Iowa  52722
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Kaiser Permanente Health Care - PortlandPortland, Oregon  97232
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Doctor's Hospital of LaredoLaredo, Texas  78041
Mountainview MedicalBerlin, Vermont  05602
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Kaiser Permanente Medical GroupLos Angeles, California  90027
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Northeast Georgia Medical CenterGainesville, Georgia  30501
Saint Luke's HospitalChesterfield, Missouri  63017
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Kaiser Permanente - Deer ValleyAntioch, California  94531
Kaiser Permanente - Moanalua Medical Center and ClinicHonolulu, Hawaii  96819
Evanston HospitalEvanston, Illinois  60201-1781
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Monter Cancer Center of the North Shore-LIJ Health SystemLake Success, New York  11042
Providence Centralia HospitalCentralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Phoebe Cancer Center at Phoebe Putney Memorial HospitalAlbany, Georgia  31702
Lowell General HospitalLowell, Massachusetts  01854
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Pardee Memorial HospitalHendersonville, North Carolina  28791
Rex Cancer Center at Rex HospitalRaleigh, North Carolina  27607
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Kaiser Permanente Medical Center - Anaheim/Orange CountyAnaheim, California  92805
Kaiser Permanente Medical Center - Baldwin ParkBaldwin Park, California  91706
Kaiser Permanente Medical Center - BellflowerBellflower, California  90706
Kaiser Permanente Medical Center - FontanaFontana, California  92335
Kaiser Permanente Medical Center - Harbor CityHarbor City, California  90710
Kaiser Foundation Hospital - West Los AngelesLos Angeles, California  90034
Kaiser Permanente Medical Center - RiversideRiverside, California  92505
Kaiser Permanente Medical Cener - Woodland HillsWoodland Hills, California  91365-4084
Resurrection Medical CenterChicago, Illinois  60631
Frederick Memorial Hospital Regional Cancer Therapy CenterFrederick, Maryland  21701
McLeod Regional Medical CenterFlorence, South Carolina  29501
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Lakes Region General HospitalLaconia, New Hampshire  03246
Cancer Center at Phoenixville HospitalPhoenixville, Pennsylvania  19460
Galesburg Clinic, PCGalesburg, Illinois  61401
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - CarthageCarthage, Illinois  62321
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - GalesburgGalesburg, Illinois  61401
Illinois CancerCare - HavanaHavana, Illinois  62644
Illinois CancerCare - Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare - MacombMacomb, Illinois  61455
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
OSF Holy Family Medical CenterMonmouth, Illinois  61462
Illinois CancerCare - MonmouthMonmouth, Illinois  61462
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PekinPekin, Illinois  61603
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - PrincetonPrinceton, Illinois  61356
Illinois CancerCare - Spring ValleySpring Valley, Illinois  61362
York Hospital's Oncology Treatment CenterYork, Maine  03909
Mercy General Health PartnersMuskegon, Michigan  49443
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Trinity CancerCare CenterMinot, North Dakota  58701
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
AnMed Cancer CenterAnderson, South Carolina  29621
High Point Regional HospitalHigh Point, North Carolina  27261
CaroMont Cancer Center at Gaston Memorial HospitalGastonia, North Carolina  28053
Addison Gilbert HospitalGloucester, Massachusetts  01930
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Central Dupage Cancer CenterWarrenville, Illinois  60555
Lakeside HospitalOmaha, Nebraska  68130
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
Providence Newberg Medical CenterNewberg, Oregon  97132
Willamette Falls HospitalOregon City, Oregon  97045
New Ulm Medical CenterNew Ulm, Minnesota  56073
Overlake Cancer Center at Overlake Hospital Medical CenterBellevue, Washington  98004
Kaiser Permanente Health CareSan Marcos, California  92069
Spectrum Health Reed City HospitalReed City, Michigan  49677
Providence Regional Cancer PartnershipEverett, Washington  98201
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460
Kaiser Permanente Medical Center - VacavilleVacaville, California  95688
St. Joseph Regional Medical CenterLewiston, Idaho  83501
Kaiser Permanente - IrvineIrvine, California  92618
Kaiser Permanente - Ontario Vineyard Medical Offices and Ambulatory SurgiCenterOntario, California  91761