Exercise and Metformin in Colorectal and Breast Cancer Survivors

Status: Recruiting
Phase: Phase 2
Diagnosis: Gastrointestinal Malignancies, Colorectal Cancer
NCT ID: NCT01340300 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-009

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Jeffrey Meyerhardt, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Gastrointestinal Research Line, 617-632-5960

Eligibility Criteria

Inclusion Criteria: - Histologically confirmed stage I-III colorectal cancer - Undergone curative-intent surgical resection and completed all adjuvant therapy within 2-24 months prior to enrollment - Less than 120 minutes of exercise per week - Approval by oncologist or surgeon - English speaking and able to read English - No planned surgery anticipated in the 6 month intervention period - At least one month from any major surgery to start of intervention including colostomy reversal Exclusion Criteria: - Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer) - Metastatic disease - Scheduled to receive any form of further adjuvant cancer therapy - Currently on medication for diabetes treatment - Pregnant or breast-feeding - Any condition associated with increased risk of metformin-associated lactic acidosis (prior renal failure or liver failure, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day) - Known hypersensitivity or intolerance to metformin
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