NCT01286233

Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 394 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Depression
• Fatigue
• Sleep Disorders

Interventions

Type	Name	Description
DRUG	Metformin
DRUG	Placebo

Timeline

• Start date: 2011-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2011-01-31
• Last updated: 2015-09-09

Locations

256 sites across 2 countries: United States, Canada