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Exercise and Metformin in Colorectal and Breast Cancer Survivors

Primary Purpose

Colorectal Cancer, Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Metformin
Educational information
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colorectal, Breast, Insulin, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale School of Medicine
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exercise training

Exercise training with metformin

Metformin

Control

Arm Description

Exercise training with exercise physiologist

Exercise training with exercise physiologist with oral metformin

Metformin

Educational information

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Other Insulin-Related Biomarkers
Markers related to insulin and insulin-like growth factors (including insulin-like growth factor 1 [IGF-1], IGF binding protein-1 [IGFBP-1], IGF binding protein-3 [IGFBP-3], leptin) will be measured by a blood draw at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.
Change in Fasting Glucose Level
Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting Glucose level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting Glucose 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.

Full Information

First Posted
April 7, 2011
Last Updated
May 3, 2018
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01340300
Brief Title
Exercise and Metformin in Colorectal and Breast Cancer Survivors
Official Title
Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Breast Cancer
Keywords
Colorectal, Breast, Insulin, Exercise

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Active Comparator
Arm Description
Exercise training with exercise physiologist
Arm Title
Exercise training with metformin
Arm Type
Active Comparator
Arm Description
Exercise training with exercise physiologist with oral metformin
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Educational information
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Two supervised exercise sessions per week
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet
Intervention Description
Oral metformin QD for two weeks, then BID
Intervention Type
Other
Intervention Name(s)
Educational information
Intervention Description
educational information
Primary Outcome Measure Information:
Title
Change in Fasting Insulin Level
Description
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.
Time Frame
0 and 3 months (change between 0 and 3 months)
Secondary Outcome Measure Information:
Title
Changes in Other Insulin-Related Biomarkers
Description
Markers related to insulin and insulin-like growth factors (including insulin-like growth factor 1 [IGF-1], IGF binding protein-1 [IGFBP-1], IGF binding protein-3 [IGFBP-3], leptin) will be measured by a blood draw at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.
Time Frame
0 and 3 months (change between 0 and 3 months)
Title
Change in Fasting Glucose Level
Description
Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting Glucose level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting Glucose 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.
Time Frame
0 and 3 months (change between 0 and 3 months)
Other Pre-specified Outcome Measures:
Title
Changes in Body Composition by Treatment Arm - Weight
Description
Negative least square means indicate a decrease at 3 month comparing to baseline value.
Time Frame
0 and 3 months (change between 0 and 3 months)
Title
Changes in Body Composition by Treatment Arm - BMI
Description
Negative least square means indicate a decrease at 3 month comparing to baseline value.
Time Frame
0 and 3 months (change between 0 and 3 months)
Title
Changes in Body Composition by Treatment Arm - Waist to Hip Ratio
Description
Negative least square means indicate a decrease at 3 month comparing to baseline value.
Time Frame
0 and 3 months (change between 0 and 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Meyerhardt, MD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Exercise and Metformin in Colorectal and Breast Cancer Survivors

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