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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT01286233
First received: January 27, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 Intervention
Breast Cancer
Depression
Fatigue
Sleep Disorders
Drug: Metformin
Drug: Placebo

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Questionnaire scores from patient reported comorbid conditions and behavioral risks [ Time Frame: Collected at baseline and 6, 12, 24, and 36 months from randomization ] [ Designated as safety issue: No ]
  • Biological correlates of fatigue (medical and demographic characteristics of pts.) [ Time Frame: Collected at baseline and 6, 12, 24, and 36 months from randomization ] [ Designated as safety issue: No ]
    Biological correlates (medical) will be collected at these timepoints. Standard demographics will be collected at baseline only.

  • DNA polymorphisms [ Time Frame: Collected at baseline ] [ Designated as safety issue: No ]
  • Changes in RNA gene expression [ Time Frame: Collected at baseline and 6, 12, and 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood sample


Enrollment: 394
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)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders 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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286233

  Show 256 Study Locations
Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT01286233     History of Changes
Other Study ID Numbers: NSABP MA.32.F, NSABP-NCIC-CTG-MA.32.F
Study First Received: January 27, 2011
Last Updated: July 7, 2014
Health Authority: Canada: Ethics Review Committee
United States: Institutional Review Board

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
fatigue
sleep disorders
depression
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Fatigue
Sleep Disorders
Parasomnias
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014