Study of Biomarkers Associated With Fatigue in Patients With Early-Stage

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01286233
Study type	Observational
Source	NSABP Foundation Inc
Contact
Status	Active, not recruiting
Phase	N/A
Start date	July 2011
Completion date	September 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms