At a glance
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Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
In Brief
A clinical study evaluating Metformin, Placebo, and 2 other interventions for Breast Neoplasms. Completed, enrolled 333 participants across 1 site.
Detailed Summary
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 intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.
Study Details
Timeline
Interventions
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
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
Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
Set of standard health education materials provided to participants at single time point (immediately after randomization)