Exercise and Metformin in Colorectal and Breast Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01340300
First received: April 7, 2011
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Breast Cancer
Behavioral: Exercise training
Drug: Exercise training plus metformin
Drug: Metformin
Other: Educational information
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months


Secondary Outcome Measures:
  • Compare changes in other insulin-related biomarkers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Markers related to insulin and insulin-like growth factors (including C peptide, insulin-like growth factor 1 [IGF-1], IGF binding protein-3 [IGFBP-3], adiponectin, lectin) will be measured by a blood draw at baseline, 3 months and 6 months

  • Explore for an interaction effect in addition to an additive effect of exercise and metformin in reducing fasting insulin level over the 3 month intervention [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Compare changes in body composition by treatment arm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measures will include body mass index (BMI) at baseline and 3 months

  • Compare change in pro-inflammatory markers potentially related to insulin resistance by treatment arm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Inflammatory markers measured in blood at baseline, 3 months and 6 months

  • Compare self-directed change in diet quality by treatment arm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Participants will complete a food frequency questionnaire at baseline and 3 months


Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise training
Exercise training with exercise physiologist
Behavioral: Exercise training
Two supervised exercise sessions per week
Active Comparator: Exercise training with metformin
Exercise training with exercise physiologist with oral metformin
Drug: Exercise training plus metformin
Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID
Active Comparator: Metformin
Metformin
Drug: Metformin
Oral metformin QD for two weeks, then BID
Active Comparator: Control
Educational information
Other: Educational information
educational information

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340300

Contacts
Contact: Jeffrey Meyerhardt, MD, MPH 617-632-6855 jeffrey_meyerhardt@dfci.harvard.edu

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Jeffrey Meyerhardt, MD, MPH         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Jeffrey Meyerhardt, MD, MPH Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jeffrey A. Meyerhardt, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01340300     History of Changes
Other Study ID Numbers: 11-009
Study First Received: April 7, 2011
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Colorectal
Breast
Insulin
Exercise

Additional relevant MeSH terms:
Rectal Diseases
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014