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

• Conditions: Fatigue; Breast Cancer; Depression; Sleep Disorders
• Interventions: Drug: Metformin; Drug: Placebo

• Registration Number: NCT01286233
• Lead Sponsor: NSABP Foundation Inc

Brief 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.

Study Timeline

• Study First Submitted: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-31
• Study Start: 2011-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 394

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: Metformin	Metformin	850 mg orally twice a day for 5 years
Group 2: Placebo	Placebo	One caplet orally twice a day for 5 years

Primary Outcome Measures

Name	Time	Method
Questionnaire scores from patient reported comorbid conditions and behavioral risks	Collected at baseline and 6, 12, 24, and 36 months from randomization
Biological correlates of fatigue (medical and demographic characteristics of pts.)	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.
Changes in RNA gene expression	Collected at baseline and 6, 12, and 24 months
Questionnaire scores from patient reported outcome battery regarding fatigue, stress, sleep, depression, and general quality of life	Collected at baseline and 6, 12, 24, and 36 months from randomization
DNA polymorphisms	Collected at baseline

Trial Locations

Locations (254)

Kaiser Permanente Medical Center - Anaheim/Orange County; 🇺🇸 Anaheim, California, United States

Kaiser Permanente - Deer Valley; 🇺🇸 Antioch, California, United States

Kaiser Permanente Medical Center - Baldwin Park; 🇺🇸 Baldwin Park, California, United States

Kaiser Permanente Medical Center - Bellflower; 🇺🇸 Bellflower, California, United States

Kaiser Permanente Medical Center - Fontana; 🇺🇸 Fontana, California, United States

Kaiser Permanente - Fremont; 🇺🇸 Fremont, California, United States

Kaiser Permanente Medical Center - Harbor City; 🇺🇸 Harbor City, California, United States

Kaiser Permanente Medical Center - Hayward; 🇺🇸 Hayward, California, United States

Kaiser Permanente - Irvine; 🇺🇸 Irvine, California, United States

Kaiser Permanente Medical Center - Los Angeles; 🇺🇸 Los Angeles, California, United States

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