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Trial record 15 of 228 for:    metformin and cancer AND Hypoglycemic

Exercise and Metformin in Colorectal and Breast Cancer Survivors

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.
ClinicalTrials.gov Identifier: NCT01340300
Recruitment Status : Completed
First Posted : April 22, 2011
Results First Posted : September 18, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute

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
Enrollment 139
Recruitment Details 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 Stratification factors: BMI (< 30 v > 30), gender, tumor site (CRC v BC)
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control
Hide Arm/Group Description

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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Period Title: Overall Study
Started 35 35 35 34
Baseline Blood Sample 33 34 32 29
Follow-up Blood Sample 25 26 19 18
Completed [1] 26 26 20 20
Not Completed 9 9 15 14
Reason Not Completed
Lost to Follow-up             3             0             5             10
Withdrawal by Subject             5             6             6             3
Adverse Event             1             0             4             0
Physician Decision             0             1             0             0
Unrelated sickness             0             2             0             1
[1]
Complete treatment and required follow-ups
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control Total
Hide Arm/Group Description

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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Total of all reporting groups
Overall Number of Baseline Participants 35 35 35 34 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 participants
53
(48 to 58)
58
(49 to 65)
55
(49 to 61)
56
(48 to 66)
55
(48 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 participants
35 35 35 34 139
Study Site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 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  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 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]
Measure Description: Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues.
Prior Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 35 participants 34 participants 139 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%
1.Primary Outcome
Title Change in Fasting Insulin Level
Time Frame 0 and 3 months (change between 0 and 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
11 patients are excluded for missing baseline blood samples.
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control
Hide Arm/Group Description:

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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Overall Number of Participants Analyzed 33 34 32 29
Least Squares Mean (Standard Error)
Unit of Measure: mU/L
-2.47  (1.07) -0.08  (1.06) -1.16  (1.18) 2.79  (1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Control
Comments Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Metformin, Control
Comments Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exercise Training, Control
Comments Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Metformin
Comments Null hypothesis: decrease of Insulin in combined arm is greater than the exercise-only or metformin-only arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
2.Secondary Outcome
Title Changes in Other Insulin-Related Biomarkers
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
11 patients are excluded for missing baseline blood samples.
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control
Hide Arm/Group Description:

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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Overall Number of Participants Analyzed 33 34 32 29
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
Leptin -5.09  (1.21) -0.54  (1.19) -2.56  (1.33) -0.20  (1.40)
IGF-I -1.29  (2.98) 8.22  (2.94) -2.66  (3.28) -3.05  (3.46)
IGFBP-1 -0.22  (0.57) 0.09  (0.56) -1.20  (0.63) 0.78  (0.66)
IGFBP-3 -178.8  (82.0) 53.4  (80.7) 25.9  (90.2) -96.9  (94.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Control
Comments Null hypothesis: decrease of leptin in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Metformin, Control
Comments Null hypothesis: decrease of IGFBP_1 in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Control
Comments Null hypothesis: decrease of IGFBP_1 in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Exercise Training
Comments Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Metformin
Comments Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
3.Secondary Outcome
Title Change in Fasting Glucose Level
Time Frame 0 and 3 months (change between 0 and 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
11 patients are excluded for missing baseline blood samples.
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control
Hide Arm/Group Description:

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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Overall Number of Participants Analyzed 33 34 32 29
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.09  (2.11) 2.93  (2.08) -4.11  (2.32) 4.92  (2.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Metformin, Control
Comments Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Control
Comments Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
4.Other Pre-specified Outcome
Title Changes in Body Composition by Treatment Arm - Weight
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients are excluded for missing baseline measurements.
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control
Hide Arm/Group Description:

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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Overall Number of Participants Analyzed 35 34 35 33
Least Squares Mean (Standard Error)
Unit of Measure: kg
-1.41  (0.53) 0.70  (0.54) -0.91  (0.57) 1.97  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Control
Comments Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Metformin, Control
Comments Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exercise Training, Control
Comments Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
5.Other Pre-specified Outcome
Title Changes in Body Composition by Treatment Arm - BMI
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients are excluded for missing baseline measurements.
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control
Hide Arm/Group Description:

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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Overall Number of Participants Analyzed 35 34 35 33
Least Squares Mean (Standard Error)
Unit of Measure: kg/m^2
-0.51  (0.20) 0.27  (0.20) -0.33  (0.21) 0.70  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Control
Comments Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Metformin, Control
Comments Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Exercise Training, Control
Comments Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
6.Other Pre-specified Outcome
Title Changes in Body Composition by Treatment Arm - Waist to Hip Ratio
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients are excluded for missing baseline measurements.
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control
Hide Arm/Group Description:

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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

Overall Number of Participants Analyzed 35 34 35 33
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.007  (0.01) 0.006  (0.01) 0.012  (0.01) 0.016  (0.01)
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Statistical Analysis Overview Comparison Group Selection Exercise Training With Metformin, Control
Comments Null hypothesis: decrease of Waist to Hip Ratio in treatment arm is greater than the control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.
Method Mixed Models Analysis
Comments An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.
Time Frame 3 months
Adverse Event Reporting Description Mortality was recorded for all patients. Non serious adverse events were collected for patients treated with Metformin (two arms: Exercise Training With Metformin, and Metformin only).
 
Arm/Group Title Exercise Training With Metformin Exercise Training Metformin Control
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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 with exercise physiologist

Exercise training: Two supervised exercise sessions per week

Metformin

Metformin: Oral metformin QD for two weeks, then BID

Educational information

Educational information: educational information

All-Cause Mortality
Exercise Training With Metformin Exercise Training Metformin Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%)   0/34 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Exercise Training With Metformin Exercise Training Metformin Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/35 (0.00%)   0/35 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exercise Training With Metformin Exercise Training Metformin Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/35 (60.00%)   0/0   23/35 (65.71%)   0/0 
Blood and lymphatic system disorders         
Blood bilirubin increased   1/35 (2.86%)  0/0  0/35 (0.00%)  0/0 
Hypertension   0/35 (0.00%)  0/0  1/35 (2.86%)  0/0 
Hypoglycemia   1/35 (2.86%)  0/0  0/35 (0.00%)  0/0 
Hypotension   1/35 (2.86%)  0/0  0/35 (0.00%)  0/0 
Cardiac disorders         
Cardiac disorders   1/35 (2.86%)  0/0  0/35 (0.00%)  0/0 
Palpitations   0/35 (0.00%)  0/0  1/35 (2.86%)  0/0 
Ear and labyrinth disorders         
Tinnitus   1/35 (2.86%)  0/0  0/35 (0.00%)  0/0 
Gastrointestinal disorders         
Diarrhea   8/35 (22.86%)  0/0  12/35 (34.29%)  0/0 
Nausea   9/35 (25.71%)  0/0  5/35 (14.29%)  0/0 
Abdomen Pain   6/35 (17.14%)  0/0  6/35 (17.14%)  0/0 
Vomiting   7/35 (20.00%)  0/0  3/35 (8.57%)  0/0 
Bloating   3/35 (8.57%)  0/0  3/35 (8.57%)  0/0 
Flatulence   2/35 (5.71%)  0/0  4/35 (11.43%)  0/0 
Constipation   1/35 (2.86%)  0/0  1/35 (2.86%)  0/0 
Anorexia   1/35 (2.86%)  0/0  0/35 (0.00%)  0/0 
Pharyngeal necrosis   0/35 (0.00%)  0/0  1/35 (2.86%)  0/0 
General disorders         
Fatigue   2/35 (5.71%)  0/0  2/35 (5.71%)  0/0 
Headache   1/35 (2.86%)  0/0  1/35 (2.86%)  0/0 
Dehydration   0/35 (0.00%)  0/0  1/35 (2.86%)  0/0 
Dry mouth   0/35 (0.00%)  0/0  1/35 (2.86%)  0/0 
Flu like symptoms   0/35 (0.00%)  0/0  1/35 (2.86%)  0/0 
Pain in extremity   1/35 (2.86%)  0/0  0/35 (0.00%)  0/0 
Musculoskeletal and connective tissue disorders         
Arthritis   1/35 (2.86%)  0/0  0/35 (0.00%)  0/0 
Indicates events were collected by systematic assessment
Limited sample size, higher than anticipated dropout, short duration of therapy
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
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: June 5, 2018