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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01286233
Recruitment Status : Unknown
Verified September 2015 by NSABP Foundation Inc.
Recruitment status was:  Active, not recruiting
First Posted : January 31, 2011
Last Update Posted : September 9, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Breast Cancer Depression Fatigue Sleep Disorders Drug: Metformin Drug: Placebo

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 394 participants
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
Study Start Date : July 2011
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Group 1: Metformin
850 mg orally twice a day for 5 years
Drug: Metformin
Group 2: Placebo
One caplet orally twice a day for 5 years
Drug: Placebo

Primary Outcome Measures :
  1. 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 ]
  2. Questionnaire scores from patient reported comorbid conditions and behavioral risks [ Time Frame: Collected at baseline and 6, 12, 24, and 36 months from randomization ]
  3. 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.

  4. DNA polymorphisms [ Time Frame: Collected at baseline ]
  5. Changes in RNA gene expression [ Time Frame: Collected at baseline and 6, 12, and 24 months ]

Biospecimen Retention:   Samples With DNA
Blood sample

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with breast cancer who have been diagnosed and have undergone definitive surgical treatment for invasive breast cancer within the previous 12 months and who are eligible for randomization to NCIC MA.32.

Inclusion Criteria

  • The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the MA.32.F Study before being enrolled.
  • The patient must be female.
  • The patient must reside in the United States or Canada.
  • The patient must be English-speaking.
  • The patient must be eligible for randomization in the MA.32 treatment trial. (Participation in the MA.32 QOL study is permitted but not required.)
  • The patient must not have started taking MA.32 study therapy.
  • The patient must have completed primary breast radiation therapy at least two weeks prior to enrollment in MA.32.F.

Exclusion Criteria

  • MA.32 study therapy has been initiated.
  • Currently receiving radiation therapy or additional radiation therapy is planned for initiation after starting MA.32 study therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01286233

  Show 256 Study Locations
Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
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Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc

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Responsible Party: NSABP Foundation Inc Identifier: NCT01286233     History of Changes
Other Study ID Numbers: NSABP MA.32.F
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by NSABP Foundation Inc:
sleep disorders
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Hypoglycemic Agents
Sleep Wake Disorders
Breast Diseases
Skin Diseases
Behavioral Symptoms
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Physiological Effects of Drugs