Exercise and Metformin in Colorectal and Breast Cancer Survivors
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Colorectal Cancer Breast Cancer |
| Intervention | Behavioral: Exercise training Drug: Exercise training plus metformin Drug: Metformin Other: Educational information |
| Phase | Phase 2 |
| Sponsor | Dana-Farber Cancer Institute |
| Responsible Party | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier | NCT01340300 |
| First Received | April 7, 2011 |
| Last Updated | April 30, 2013 |
| Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 7, 2011 |
|---|---|
| Last Updated Date | April 30, 2013 |
| Start Date | May 2011 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | 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] [Designated as safety issue: No]Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Exercise and Metformin in Colorectal and Breast Cancer Survivors |
|---|---|
| Official Title | Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors |
| Brief Summary | 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. |
| Detailed Description | 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic |
| Condition |
|
| Intervention | Behavioral: Exercise training Two supervised exercise sessions per week Drug: Exercise training plus metformin Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID Drug: Metformin Oral metformin QD for two weeks, then BID Other: Educational information educational information |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 200 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | May 2014 |
| Eligibility Criteria | Inclusion Criteria: - Histologically confirmed stage I-III colorectal or breast cancer - Undergone curative-intent complete surgical resection and completed all adjuvant therapy (if indicated) at least 2 months prior to enrollment - Note: Breast cancer subjects on hormonal therapy or trastuzumab only therapy and colorectal cancer subjects on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in CALGB 80702 receiving only celocoxib/placebo) are eligible. - Participants will be allowed to receive concomitant adjuvant endocrine therapy for breast cancer; however, all endocrine agents must be initiated at least 1 month prior to enrollment in the study and continued throughout the duration of study participation. - 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 3 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Jeffrey Meyerhardt, MD, MPH 617-632-6855 jeffrey_meyerhardt@dfci.harvard.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01340300 |
|---|---|
| Other Study ID Numbers | 11-009 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Dana-Farber Cancer Institute |
| Study Sponsor | Dana-Farber Cancer Institute |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Jeffrey Meyerhardt, MD, MPH Dana-Farber Cancer Institute |
| Verification Date | April 2013 |
Locations[ + expand ][ + ]
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States, 02215 Principal Investigator: Jeffrey Meyerhardt, MD, MPHRecruiting |
|---|---|
| Duke University | Durham, North Carolina, United States, 27710 Principal Investigator: Lee Jones, PhDRecruiting |