Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Metformin

Insulin

Insulin, Globin Zinc

Exercise training with exercise physiologist

Exercise training with exercise physiologist with oral metformin

Two supervised exercise sessions per week

Exercise training

Oral metformin QD for two weeks, then BID

Educational information

Jeffrey Meyerhardt, MD, MPH

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.

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.

Exercise and Metformin in Colorectal and Breast Cancer Survivors

Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors

Negative least square means indicate a decrease at 3 month comparing to baseline value.

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. Negative least square means indicate a decrease at 3 month comparing to baseline value.

Markers related to insulin and insulin-like growth factors (including insulin-like growth factor 1 \[IGF-1\], IGF binding protein-1 \[IGFBP-1\], IGF binding protein-3 \[IGFBP-3\], leptin) will be measured by a blood draw at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.

Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting Glucose level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting Glucose levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.

Dana-Farber Cancer Institute

Principal Investigator

Mortality was recorded for all patients. Non serious adverse events were collected for patients treated with Metformin (two arms: Exercise Training With Metformin, and Metformin only).

Exercise training with exercise physiologist with oral metformin

Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID

Exercise Training With Metformin

Exercise training with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Exercise Training

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study Site

Tumor Location

Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues.

Cancer Stage

Prior Chemotherapy

Prior Radiation Therapy

Limited sample size, higher than anticipated dropout, short duration of therapy

Meyerhardt, Jeffrey,M.D.,M.P.H.

Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.

Null hypothesis: decrease of Insulin in combined arm is greater than the exercise-only or metformin-only arm.

11 patients are excluded for missing baseline blood samples.

Change in Fasting Insulin Level

Null hypothesis: decrease of leptin in treatment arm is greater than the control arm.

Null hypothesis: decrease of IGFBP_1 in treatment arm is greater than the control arm.

Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.

Leptin

IGF-I

IGFBP-1

IGFBP-3

Changes in Other Insulin-Related Biomarkers

Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.

Change in Fasting Glucose Level

Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.

2 patients are excluded for missing baseline measurements.

Changes in Body Composition by Treatment Arm - Weight

Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.

Changes in Body Composition by Treatment Arm - BMI

Null hypothesis: decrease of Waist to Hip Ratio in treatment arm is greater than the control arm.

Spots Global Cancer Trial Database for educational information