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Exercise and Metformin in Colorectal and Breast Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340300
First Posted: April 22, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
Results First Submitted: July 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Colorectal Cancer
Breast Cancer
Interventions: Behavioral: Exercise training
Drug: Metformin
Other: Educational information

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In a phase 2 RCT, stage I-III CRC & BC survivors at least 2 months from completing standard therapy were randomized. Major eligibility included absence of recurrence, absence of diabetes (glucose < 160 (random) or < 126 (fasting) mg/dl), and exercising < 120 min/wk. 1,426 patients screened, and 139 enrolled from September 2011 to December 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Stratification factors: BMI (< 30 v > 30), gender, tumor site (CRC v BC)

Reporting Groups
  Description
Exercise Training With Metformin

Exercise training with exercise physiologist with oral metformin

Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID

Exercise Training

Exercise training with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Control

Educational information

Educational information: educational information


Participant Flow:   Overall Study
    Exercise Training With Metformin   Exercise Training   Metformin   Control
STARTED   35   35   35   34 
Baseline Blood Sample   33   34   32   29 
Follow-up Blood Sample   25   26   19   17 
Completed Treatment   23   24   18   17 
COMPLETED [1]   20   21   14   13 
NOT COMPLETED   15   14   21   21 
Lost to Follow-up                7                3                12                17 
Withdrawal by Subject                5                8                6                3 
Adverse Event                0                0                2                0 
Physician Decision                2                1                1                0 
Unrelated sickness, moving                1                2                0                1 
[1] Complete treatment and required follow-ups



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exercise Training With Metformin

Exercise training with exercise physiologist with oral metformin

Exercise training plus metformin: Two supervised exercise sessions per week. Oral metformin QD for 2 weeks, then BID

Exercise Training

Exercise training with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Control

Educational information

Educational information: educational information

Total Total of all reporting groups

Baseline Measures
   Exercise Training With Metformin   Exercise Training   Metformin   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   35   35   34   139 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 53 
 (48 to 58) 
 58 
 (49 to 65) 
 55 
 (49 to 61) 
 56 
 (48 to 66) 
 55 
 (48 to 64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      29  82.9%      29  82.9%      29  82.9%      29  85.3%      116  83.5% 
Male      6  17.1%      6  17.1%      6  17.1%      5  14.7%      23  16.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      0   0.0%      0   0.0%      1   2.9%      0   0.0%      1   0.7% 
Not Hispanic or Latino      31  88.6%      35 100.0%      34  97.1%      33  97.1%      133  95.7% 
Unknown or Not Reported      4  11.4%      0   0.0%      0   0.0%      1   2.9%      5   3.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      2   5.7%      2   5.7%      1   2.9%      2   5.9%      7   5.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   8.6%      1   2.9%      3   8.6%      5  14.7%      12   8.6% 
White      28  80.0%      30  85.7%      29  82.9%      26  76.5%      113  81.3% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   5.7%      2   5.7%      2   5.7%      1   2.9%      7   5.0% 
Region of Enrollment 
[Units: Participants]
         
United States   35   35   35   34   139 
Study Site 
[Units: Participants]
Count of Participants
         
DFCI      28  80.0%      22  62.9%      24  68.6%      25  73.5%      99  71.2% 
Duke      4  11.4%      4  11.4%      5  14.3%      6  17.6%      19  13.7% 
Yale      3   8.6%      9  25.7%      6  17.1%      3   8.8%      21  15.1% 
BMI 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 27.7 
 (25.5 to 34.2) 
 28.5 
 (26.4 to 32.8) 
 28.8 
 (25.3 to 33.9) 
 28.4 
 (25.5 to 31.9) 
 28.5 
 (25.6 to 33.2) 
Tumor Location 
[Units: Participants]
Count of Participants
         
Breast Cancer      22  62.9%      21  60.0%      22  62.9%      22  64.7%      87  62.6% 
Colorectal Cancer      13  37.1%      14  40.0%      13  37.1%      12  35.3%      52  37.4% 
Cancer Stage [1] 
[Units: Participants]
Count of Participants
         
stage I      14  40.0%      11  31.4%      14  40.0%      12  35.3%      51  36.7% 
stage II      8  22.9%      11  31.4%      9  25.7%      12  35.3%      40  28.8% 
stage III      13  37.1%      12  34.3%      12  34.3%      9  26.5%      46  33.1% 
Unknown stage      0   0.0%      1   2.9%      0   0.0%      1   2.9%      2   1.4% 
[1] Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues.
Prior Chemotherapy 
[Units: Participants]
Count of Participants
         
Yes      25  71.4%      22  62.9%      23  65.7%      22  64.7%      92  66.2% 
No      10  28.6%      9  25.7%      12  34.3%      11  32.4%      42  30.2% 
Unknown      0   0.0%      4  11.4%      0   0.0%      1   2.9%      5   3.6% 
Prior Radiation Therapy 
[Units: Participants]
Count of Participants
         
Yes      17  48.6%      16  45.7%      14  40.0%      16  47.1%      63  45.3% 
No      18  51.4%      15  42.9%      21  60.0%      17  50.0%      71  51.1% 
Unknown      0   0.0%      4  11.4%      0   0.0%      1   2.9%      5   3.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Fasting Insulin Level   [ Time Frame: 0 and 3 months (change between 0 and 3 months) ]

2.  Secondary:   Changes in Other Insulin-Related Biomarkers   [ Time Frame: 0 and 3 months (change between 0 and 3 months) ]

3.  Secondary:   Change in Fasting Glucose Level   [ Time Frame: 0 and 3 months (change between 0 and 3 months) ]

4.  Other Pre-specified:   Changes in Body Composition by Treatment Arm - Weight   [ Time Frame: 0 and 3 months (change between 0 and 3 months) ]

5.  Other Pre-specified:   Changes in Body Composition by Treatment Arm - BMI   [ Time Frame: 0 and 3 months (change between 0 and 3 months) ]

6.  Other Pre-specified:   Changes in Body Composition by Treatment Arm - Waist to Hip Ratio   [ Time Frame: 0 and 3 months (change between 0 and 3 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limited sample size, higher than anticipated dropout, short duration of therapy


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Meyerhardt, Jeffrey,M.D.,M.P.H.
Organization: Dana-Farber Cancer Institute
phone: 617-632-6855
e-mail: Jeffrey_Meyerhardt@dfci.harvard.edu



Responsible Party: Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01340300     History of Changes
Other Study ID Numbers: 11-009
First Submitted: April 7, 2011
First Posted: April 22, 2011
Results First Submitted: July 11, 2017
Results First Posted: September 18, 2017
Last Update Posted: October 12, 2017