Exercise and Metformin in Colorectal and Breast Cancer Survivors

NCT01340300 | Completed Phase 2 Results DMC

• 1 other identifier: 11-009
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer; Breast Cancer

Keywords

Colorectal; Breast; Insulin; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Fasting Insulin Level

  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. Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.

  0 and 3 months (change between 0 and 3 months)

Secondary Outcomes (2)

• Changes in Other Insulin-Related Biomarkers

  0 and 3 months (change between 0 and 3 months)

• Change in Fasting Glucose Level

  0 and 3 months (change between 0 and 3 months)

Other Outcomes (3)

• Changes in Body Composition by Treatment Arm - Weight

  0 and 3 months (change between 0 and 3 months)

• Changes in Body Composition by Treatment Arm - BMI

  0 and 3 months (change between 0 and 3 months)

• Changes in Body Composition by Treatment Arm - Waist to Hip Ratio

  0 and 3 months (change between 0 and 3 months)

Study Arms (4)

Exercise training

ACTIVE COMPARATOR

Exercise training with exercise physiologist

Behavioral: Exercise training

Exercise training with metformin

ACTIVE COMPARATOR

Exercise training with exercise physiologist with oral metformin

Behavioral: Exercise training; Drug: Metformin

Metformin

ACTIVE COMPARATOR

Metformin

Drug: Metformin

Control

ACTIVE COMPARATOR

Educational information

Other: Educational information

Interventions

Exercise training BEHAVIORAL

Two supervised exercise sessions per week

Exercise training; Exercise training with metformin

Metformin DRUG

Oral metformin QD for two weeks, then BID

Also known as: Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet

Exercise training with metformin; Metformin

Educational information OTHER

educational information

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms; Insulin Resistance; Motor Activity

Interventions

Exercise; Metformin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

Limited sample size, higher than anticipated dropout, short duration of therapy

Results Point of Contact

• Title: Meyerhardt, Jeffrey,M.D.,M.P.H.
• Organization: Dana-Farber Cancer Institute

Jeffrey_Meyerhardt@dfci.harvard.edu

617-632-6855

Study Officials

• Jeffrey Meyerhardt, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 22, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2017
• Last Updated: June 6, 2018
• Results First Posted: September 18, 2017

Record last verified: 2018-05

Locations

US (2)