Exercise and Metformin in Colorectal and Breast Cancer Survivors

NCT ID: NCT01340300

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Colorectal Cancer; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Exercise training

Exercise training with exercise physiologist

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: BEHAVIORAL

Two supervised exercise sessions per week

Exercise training with metformin

Exercise training with exercise physiologist with oral metformin

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: BEHAVIORAL

Two supervised exercise sessions per week

Metformin

Intervention Type: DRUG

Oral metformin QD for two weeks, then BID

Metformin

Metformin

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Oral metformin QD for two weeks, then BID

Control

Educational information

Group Type: ACTIVE_COMPARATOR

Educational information

Intervention Type: OTHER

educational information

Interventions

Exercise training

Two supervised exercise sessions per week

Intervention Type: BEHAVIORAL

Metformin

Oral metformin QD for two weeks, then BID

Intervention Type: DRUG

Educational information

educational information

Intervention Type: OTHER

Other Intervention Names

Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey A. Meyerhardt, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Meyerhardt, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-009

Identifier Type: -

Identifier Source: org_study_id