Trial record 1 of 1 for:    NCIC CTG MA.32
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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

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: May 17, 2013
Last verified: May 2013

January 27, 2011
May 17, 2013
July 2011
September 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • Other items from FSI [ Designated as safety issue: No ]
  • PROMIS fatigue measure [ Designated as safety issue: No ]
  • Fatigue Symptom Inventory (FSI) composite score obtained over a course of 5 years post-randomization [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01286233 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood sample

Non-Probability Sample

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.

  • Breast Cancer
  • Depression
  • Fatigue
  • Sleep Disorders
  • Drug: Metformin
  • Drug: Placebo
  • Group 1: Metformin
    850 mg orally twice a day for 5 years
    Intervention: Drug: Metformin
  • Group 2: Placebo
    One caplet orally twice a day for 5 years
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
394
September 2016
September 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01286233
NSABP MA.32.F, NSABP-NCIC-CTG-MA.32.F
No
National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Cancer Institute (NCI)
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
National Surgical Adjuvant Breast and Bowel Project (NSABP)
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP