Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors
18 Years
N/A
Both
Colorectal Cancer, Breast Cancer
Trial Information
Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
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.
Outcome Description:
Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Jeffrey Meyerhardt, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
11-009
NCT ID:
NCT01340300
Start Date:
May 2011
Completion Date:
Related Keywords:
- Colorectal Cancer
- Breast Cancer
- Colorectal
- Breast
- Insulin
- Exercise
- Breast Neoplasms
- Colorectal Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Duke University | Durham, North Carolina 27710 |
