Phase 2
N=139
Exercise and Metformin in Colorectal and Breast Cancer Survivors
Colorectal Cancer · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01340300 ↗Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Change in Fasting Insulin Level — -2.47; -0.08; -1.16; 2.79 mU/L — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exercise training (Behavioral); Metformin (Drug); Educational information (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fasting Insulin Level |
-2.47; -0.08; -1.16; 2.79 | <0.0001 sig |
| SECONDARY Changes in Other Insulin-Related Biomarkers |
-5.09; -0.54; -2.56; -0.20; -1.29; 8.22 | 0.0002 sig |
| SECONDARY Change in Fasting Glucose Level |
-0.09; 2.93; -4.11; 4.92 | 0.0004 sig |
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.
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 celecoxib/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
Data sourced from ClinicalTrials.gov (NCT01340300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.