Exercise and Metformin in Colorectal and Breast Cancer Survivors
Metformin is a medication that is commonly used in the treatment of diabetes. Recently small studies in cancer patients without diabetes suggest that metformin may benefit in lowering insulin levels. In those studies of patients with cancer but not diabetes, glucose (or sugar) levels in the blood are generally no lowered. Insulin and insulin-like growth factors affect the growth of cancer cells.
This randomized study will compare different interventions; exercise, exercise and metformin, metformin alone, or a control arm. The investigators are not directly testing how either exercise or metformin affects your disease. The investigators are testing how they affect insulin levels in your body as well as other blood markers. The investigators believe that these blood tests may either be related to cancer recurrences or be an early sign of cancer recurrences and they are testing how both exercise and metformin may change those markers.
|Colorectal Cancer Breast Cancer||Behavioral: Exercise training Drug: Exercise training plus metformin Drug: Metformin Other: Educational information||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors|
- 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. [ Time Frame: 3 years ]Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months
- Compare changes in other insulin-related biomarkers [ Time Frame: 3 years ]Markers related to insulin and insulin-like growth factors (including C peptide, insulin-like growth factor 1 [IGF-1], IGF binding protein-3 [IGFBP-3], adiponectin, lectin) will be measured by a blood draw at baseline, 3 months and 6 months
- Explore for an interaction effect in addition to an additive effect of exercise and metformin in reducing fasting insulin level over the 3 month intervention [ Time Frame: 3 years ]
- Compare changes in body composition by treatment arm [ Time Frame: 3 years ]Measures will include body mass index (BMI) at baseline and 3 months
- Compare change in pro-inflammatory markers potentially related to insulin resistance by treatment arm [ Time Frame: 3 years ]Inflammatory markers measured in blood at baseline, 3 months and 6 months
- Compare self-directed change in diet quality by treatment arm [ Time Frame: 3 years ]Participants will complete a food frequency questionnaire at baseline and 3 months
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Exercise training
Exercise training with exercise physiologist
Behavioral: Exercise training
Two supervised exercise sessions per week
Active Comparator: Exercise training with metformin
Exercise training with exercise physiologist with oral metformin
Drug: Exercise training plus metformin
Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID
Active Comparator: Metformin
Oral metformin QD for two weeks, then BID
Active Comparator: Control
Other: Educational information
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340300
|United States, Connecticut|
|Yale School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jeffrey Meyerhardt, MD, MPH||Dana-Farber Cancer Institute|