Trial Outcomes & Findings for Exercise and Metformin in Colorectal and Breast Cancer Survivors (NCT NCT01340300)
NCT ID: NCT01340300
Last Updated: 2018-06-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
139 participants
Primary outcome timeframe
0 and 3 months (change between 0 and 3 months)
Results posted on
2018-06-06
Participant Flow
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.
Stratification factors: BMI (\< 30 v \> 30), gender, tumor site (CRC v BC)
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
34
|
|
Overall Study
Baseline Blood Sample
|
33
|
34
|
32
|
29
|
|
Overall Study
Follow-up Blood Sample
|
25
|
26
|
19
|
18
|
|
Overall Study
COMPLETED
|
26
|
26
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
15
|
14
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
5
|
10
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
6
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
4
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Unrelated sickness
|
0
|
2
|
0
|
1
|
Baseline Characteristics
Exercise and Metformin in Colorectal and Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Exercise Training With Metformin
n=35 Participants
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
n=35 Participants
Exercise training with exercise physiologist
Exercise training: Two supervised exercise sessions per week
|
Metformin
n=35 Participants
Metformin
Metformin: Oral metformin QD for two weeks, then BID
|
Control
n=34 Participants
Educational information
Educational information: educational information
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
58 years
n=7 Participants
|
55 years
n=5 Participants
|
56 years
n=4 Participants
|
55 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
35 participants
n=5 Participants
|
34 participants
n=4 Participants
|
139 participants
n=21 Participants
|
|
Study Site
DFCI
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Study Site
Duke
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Study Site
Yale
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
BMI
|
27.7 kg/m^2
n=5 Participants
|
28.5 kg/m^2
n=7 Participants
|
28.8 kg/m^2
n=5 Participants
|
28.4 kg/m^2
n=4 Participants
|
28.5 kg/m^2
n=21 Participants
|
|
Tumor Location
Breast Cancer
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Tumor Location
Colorectal Cancer
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Cancer Stage
stage I
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Cancer Stage
stage II
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Cancer Stage
stage III
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Cancer Stage
Unknown stage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Prior Chemotherapy
Yes
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Prior Chemotherapy
No
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Prior Chemotherapy
Unknown
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Prior Radiation Therapy
Yes
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Prior Radiation Therapy
No
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Prior Radiation Therapy
Unknown
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0 and 3 months (change between 0 and 3 months)Population: 11 patients are excluded for missing baseline blood samples.
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.
Outcome measures
| Measure |
Exercise Training With Metformin
n=33 Participants
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
n=34 Participants
Exercise training with exercise physiologist
Exercise training: Two supervised exercise sessions per week
|
Metformin
n=32 Participants
Metformin
Metformin: Oral metformin QD for two weeks, then BID
|
Control
n=29 Participants
Educational information
Educational information: educational information
|
|---|---|---|---|---|
|
Change in Fasting Insulin Level
|
-2.47 mU/L
Standard Error 1.07
|
-0.08 mU/L
Standard Error 1.06
|
-1.16 mU/L
Standard Error 1.18
|
2.79 mU/L
Standard Error 1.27
|
SECONDARY outcome
Timeframe: 0 and 3 months (change between 0 and 3 months)Population: 11 patients are excluded for missing baseline blood samples.
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.
Outcome measures
| Measure |
Exercise Training With Metformin
n=33 Participants
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
n=34 Participants
Exercise training with exercise physiologist
Exercise training: Two supervised exercise sessions per week
|
Metformin
n=32 Participants
Metformin
Metformin: Oral metformin QD for two weeks, then BID
|
Control
n=29 Participants
Educational information
Educational information: educational information
|
|---|---|---|---|---|
|
Changes in Other Insulin-Related Biomarkers
Leptin
|
-5.09 ng/mL
Standard Error 1.21
|
-0.54 ng/mL
Standard Error 1.19
|
-2.56 ng/mL
Standard Error 1.33
|
-0.20 ng/mL
Standard Error 1.40
|
|
Changes in Other Insulin-Related Biomarkers
IGF-I
|
-1.29 ng/mL
Standard Error 2.98
|
8.22 ng/mL
Standard Error 2.94
|
-2.66 ng/mL
Standard Error 3.28
|
-3.05 ng/mL
Standard Error 3.46
|
|
Changes in Other Insulin-Related Biomarkers
IGFBP-1
|
-0.22 ng/mL
Standard Error 0.57
|
0.09 ng/mL
Standard Error 0.56
|
-1.20 ng/mL
Standard Error 0.63
|
0.78 ng/mL
Standard Error 0.66
|
|
Changes in Other Insulin-Related Biomarkers
IGFBP-3
|
-178.8 ng/mL
Standard Error 82.0
|
53.4 ng/mL
Standard Error 80.7
|
25.9 ng/mL
Standard Error 90.2
|
-96.9 ng/mL
Standard Error 94.9
|
SECONDARY outcome
Timeframe: 0 and 3 months (change between 0 and 3 months)Population: 11 patients are excluded for missing baseline blood samples.
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.
Outcome measures
| Measure |
Exercise Training With Metformin
n=33 Participants
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
n=34 Participants
Exercise training with exercise physiologist
Exercise training: Two supervised exercise sessions per week
|
Metformin
n=32 Participants
Metformin
Metformin: Oral metformin QD for two weeks, then BID
|
Control
n=29 Participants
Educational information
Educational information: educational information
|
|---|---|---|---|---|
|
Change in Fasting Glucose Level
|
-0.09 mg/dL
Standard Error 2.11
|
2.93 mg/dL
Standard Error 2.08
|
-4.11 mg/dL
Standard Error 2.32
|
4.92 mg/dL
Standard Error 2.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 and 3 months (change between 0 and 3 months)Population: 2 patients are excluded for missing baseline measurements.
Negative least square means indicate a decrease at 3 month comparing to baseline value.
Outcome measures
| Measure |
Exercise Training With Metformin
n=35 Participants
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
n=34 Participants
Exercise training with exercise physiologist
Exercise training: Two supervised exercise sessions per week
|
Metformin
n=35 Participants
Metformin
Metformin: Oral metformin QD for two weeks, then BID
|
Control
n=33 Participants
Educational information
Educational information: educational information
|
|---|---|---|---|---|
|
Changes in Body Composition by Treatment Arm - Weight
|
-1.41 kg
Standard Error 0.53
|
0.70 kg
Standard Error 0.54
|
-0.91 kg
Standard Error 0.57
|
1.97 kg
Standard Error 0.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 and 3 months (change between 0 and 3 months)Population: 2 patients are excluded for missing baseline measurements.
Negative least square means indicate a decrease at 3 month comparing to baseline value.
Outcome measures
| Measure |
Exercise Training With Metformin
n=35 Participants
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
n=34 Participants
Exercise training with exercise physiologist
Exercise training: Two supervised exercise sessions per week
|
Metformin
n=35 Participants
Metformin
Metformin: Oral metformin QD for two weeks, then BID
|
Control
n=33 Participants
Educational information
Educational information: educational information
|
|---|---|---|---|---|
|
Changes in Body Composition by Treatment Arm - BMI
|
-0.51 kg/m^2
Standard Error 0.20
|
0.27 kg/m^2
Standard Error 0.20
|
-0.33 kg/m^2
Standard Error 0.21
|
0.70 kg/m^2
Standard Error 0.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 and 3 months (change between 0 and 3 months)Population: 2 patients are excluded for missing baseline measurements.
Negative least square means indicate a decrease at 3 month comparing to baseline value.
Outcome measures
| Measure |
Exercise Training With Metformin
n=35 Participants
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
n=34 Participants
Exercise training with exercise physiologist
Exercise training: Two supervised exercise sessions per week
|
Metformin
n=35 Participants
Metformin
Metformin: Oral metformin QD for two weeks, then BID
|
Control
n=33 Participants
Educational information
Educational information: educational information
|
|---|---|---|---|---|
|
Changes in Body Composition by Treatment Arm - Waist to Hip Ratio
|
-0.007 ratio
Standard Error 0.01
|
0.006 ratio
Standard Error 0.01
|
0.012 ratio
Standard Error 0.01
|
0.016 ratio
Standard Error 0.01
|
Adverse Events
Exercise Training With Metformin
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Exercise Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercise Training With Metformin
n=35 participants at risk
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
n=35 participants at risk
Exercise training with exercise physiologist
Exercise training: Two supervised exercise sessions per week
|
Metformin
n=35 participants at risk
Metformin
Metformin: Oral metformin QD for two weeks, then BID
|
Control
n=34 participants at risk
Educational information
Educational information: educational information
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
22.9%
8/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
34.3%
12/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Gastrointestinal disorders
Nausea
|
25.7%
9/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
14.3%
5/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Gastrointestinal disorders
Abdomen Pain
|
17.1%
6/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
17.1%
6/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
7/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
8.6%
3/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Gastrointestinal disorders
Bloating
|
8.6%
3/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
8.6%
3/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
2/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
11.4%
4/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
General disorders
Fatigue
|
5.7%
2/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
5.7%
2/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
General disorders
Headache
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Gastrointestinal disorders
Anorexia
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Cardiac disorders
Cardiac disorders
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
General disorders
Dehydration
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
General disorders
Dry mouth
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
General disorders
Flu like symptoms
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Blood and lymphatic system disorders
Hypertension
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Blood and lymphatic system disorders
Hypotension
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
General disorders
Pain in extremity
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Gastrointestinal disorders
Pharyngeal necrosis
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
0.00%
0/35 • 3 months
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).
|
—
0/0 • 3 months
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).
|
Additional Information
Meyerhardt, Jeffrey,M.D.,M.P.H.
Dana-Farber Cancer Institute
Phone: 617-632-6855
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place