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
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
RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue.
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.
OBJECTIVES:
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
Exclusion Criteria
Ontario, California 91761, United States
San Diego, California 92120, United States
San Francisco, California 94115, United States
Santa Clara, California 95051, United States
South San Francisco, California 94080, United States
Washington D.C., District of Columbia 20007, United States
Maywood, Illinois 60153, United States
Moline, Illinois 61265, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
La Porte, Indiana 46350, United States
Wichita, Kansas 67214, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Concord, New Hampshire 03301, United States
Marlton, New Jersey 08053, United States
Voorhees Township, New Jersey 08043, United States
East Syracuse, New York 13057, United States
Lake Success, New York 11042, United States
Manhasset, New York 11030, United States
New York, New York 10032, United States
Pinehurst, North Carolina 28374, United States
Winston-Salem, North Carolina 27157-1096, United States
Portland, Oregon 97213-2967, United States
Spartanburg, South Carolina 29303, United States
Burlington, Vermont 05401, United States
Green Bay, Wisconsin 54301-3526, United States
Saint Catharines, Ontario L2R 2Z7, Canada