Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||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|
- Questionnaire scores from patient reported outcome battery regarding fatigue, stress, sleep, depression, and general quality of life [ Time Frame: Collected at baseline and 6, 12, 24, and 36 months from randomization ]
- Questionnaire scores from patient reported comorbid conditions and behavioral risks [ Time Frame: Collected at baseline and 6, 12, 24, and 36 months from randomization ]
- Biological correlates of fatigue (medical and demographic characteristics of pts.) [ Time Frame: Collected at baseline and 6, 12, 24, and 36 months from randomization ]Biological correlates (medical) will be collected at these timepoints. Standard demographics will be collected at baseline only.
- DNA polymorphisms [ Time Frame: Collected at baseline ]
- Changes in RNA gene expression [ Time Frame: Collected at baseline and 6, 12, and 24 months ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Group 1: Metformin
850 mg orally twice a day for 5 years
Group 2: Placebo
One caplet orally twice a day for 5 years
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286233
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|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|