Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.