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Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Ruth E. Patterson, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01302379
First received: February 23, 2011
Last updated: August 27, 2012
Last verified: August 2012

February 23, 2011
August 27, 2012
August 2011
December 2014   (final data collection date for primary outcome measure)
Biological markers associated with breast cancer survival [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01302379 on ClinicalTrials.gov Archive Site
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Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
Obesity-related Mechanisms and Mortality in Breast Cancer Survivors

This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.

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Interventional
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Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Breast Neoplasms
  • Drug: Metformin
    Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
  • Drug: Placebo
    Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
    Other Name: Sugar pill
  • Behavioral: Lifestyle intervention
    Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
  • Behavioral: Standard printed dietary guidelines
    Set of standard health education materials provided to participants at single time point (immediately after randomization)
  • Active Comparator: Metformin + lifestyle intervention
    Interventions:
    • Drug: Metformin
    • Behavioral: Lifestyle intervention
  • Active Comparator: Placebo + lifestyle intervention
    Interventions:
    • Drug: Placebo
    • Behavioral: Lifestyle intervention
  • Active Comparator: Metformin + standard dietary guidelines
    Interventions:
    • Drug: Metformin
    • Behavioral: Standard printed dietary guidelines
  • Placebo Comparator: Placebo + standard dietary guidelines
    Interventions:
    • Drug: Placebo
    • Behavioral: Standard printed dietary guidelines
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
340
July 2016
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI at least 25.0 kg/m2
  • Diagnosed with Stage I, II, or III breast cancer within past 5 years
  • Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
  • Not scheduled for or currently undergoing chemotherapy
  • Accessible geographically and by telephone
  • Able to communicate dietary and physical activity data via telephone
  • If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
  • Post-menopausal at diagnosis

Exclusion Criteria:

  • Preliminary bloodwork outside of specified ranges
  • Evidence of renal insufficiency, liver disease, or congestive heart failure
  • Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
  • Recent initiation (< 3 months ago) of thiazides or β-blockers
  • Taking insulin or other antidiabetic drug
  • Other primary or recurrent invasive cancer in past 10 years
  • Unable to commit to study requirements
Female
Not Provided
No
Contact: Jesica Oratowski Coleman 8588223311 joratowski@ucsd.edu
Contact: Lisa Bertram, PhD 8588226799 lcadmus@ucsd.edu
United States
 
NCT01302379
U54 CA155435-01 Project 3
Yes
Ruth E. Patterson, University of California, San Diego
University of California, San Diego
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Not Provided
University of California, San Diego
August 2012

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