Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors
Subjects will be randomized into one of four groups: exercise training, exercise training
and metformin, metformin alone, or control arm. All subjects will have lifestyle
measurements, interviews regarding activity level, diet questionnaires, and blood tests.
Subjects randomized to exercise training will participate in two supervised exercise
sessions per week with an exercise physiologist for 3 months. They will also be asked to
exercise on their own for up to an additional 120 minutes each week.
Subjects randomized to exercise training and metformin will participate in two supervised
exercise sessions per week and will take metformin. Metformin will be taken once daily for
the first two weeks and then twice daily for 3 months.
Subjects randomized to metformin will take metformin once daily for the first two weeks and
then twice daily.
Subjects on the control arm will receive a packet of educational information on nutrition
and physical activity developed by the National Cancer Institute and American Cancer
Society. In addition to education information, they will be offered two supervised sessions
with an exercise physiologist as well as a pedometer 3 months after enrollment in the study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting insulin level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer.
Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months
Jeffrey Meyerhardt, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Duke University||Durham, North Carolina 27710|