CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 139 enrolled
Drug / intervention
Metformin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01340300
NCT01340300Phase 2Completed

Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors

Dana-Farber Cancer Institute·interventional·Posted Apr 22, 2011·Updated Jun 6, 2018

In Brief

A Phase 2 clinical trial evaluating Exercise training, Metformin, and 1 other intervention for Colorectal Cancer and Breast Cancer. Completed, enrolled 139 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2011
Enrollment StartMay 1, 2011
Primary CompletionJan 1, 2016
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.2 years ago

Interventions

Exercise trainingbehavioral

Two supervised exercise sessions per week

Metformindrug

Oral metformin QD for two weeks, then BID

Educational informationother

educational information