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Exercise and Metformin in Colorectal and Breast Cancer Survivors

NCT01340300 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2018-06-06

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Exercise training

Two supervised exercise sessions per week

DRUG

Metformin

Oral metformin QD for two weeks, then BID

OTHER

Educational information

educational information

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Meyerhardt, MD, MPH · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2016-01-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340300 on ClinicalTrials.gov