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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
333
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)
Moores UCSD Cancer Center
La Jolla, California, United States
Insulin
Insulin measured as percent change from baseline
Time frame: change from baseline to 6 months
Glucose
Glucose measured as percent change from baseline
Time frame: change from baseline to 6 months
C-reactive Protein
C-reactive protein measured as percent change from baseline
Time frame: change from baseline to 6 months
Bioavailable Testosterone
Bioavailable testosterone measured as percent change from baseline
Time frame: change from baseline to 6 months
Serum Hormone Binding Globulin
Serum hormone binding globulin measured as percent change from baseline
Time frame: change from baseline to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.