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Trial record 3 of 228 for:    metformin and cancer AND Hypoglycemic

Metformin for Rising PSA Remote Trial (M-RePoRT)

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: NCT02376166
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Matthew Galsky, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Prostate Cancer
Intervention Drug: Metformin
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin
Hide Arm/Group Description

850 mg PO once daily for 4 weeks

Metformin: 850 mg PO twice daily for the remainder of the study period (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)

Period Title: Overall Study
Started 15
Completed 12
Not Completed 3
Reason Not Completed
Adverse Event             1
Discontinued metformin early             2
Arm/Group Title Metformin
Hide Arm/Group Description 850 mg PO once daily for 4 weeks
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
68
(57 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Gleason Score   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
7
(6 to 9)
[1]
Measure Description: A system of grading prostate cancer tissue based on how it looks under a microscope. Gleason scores range from 2 to 10 and indicate how likely it is that a tumor will spread. A low Gleason score means the cancer tissue is similar to normal prostate tissue and the tumor is less likely to spread; a high Gleason score means the cancer tissue is very different from normal and the tumor is more likely to spread.
Primary Treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Radical prostatectomy
12
  80.0%
Radiation therapy
3
  20.0%
Years from local therapy to study enrollment  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
5.9
(1.2 to 16.0)
Baseline PSA  
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 15 participants
4.1
(0.52 to 31.7)
One-way driving distance to study center  
Median (Full Range)
Unit of measure:  Miles
Number Analyzed 15 participants
63.2
(2.4 to 146)
One-way driving time to study center  
Median (Full Range)
Unit of measure:  Minutes
Number Analyzed 15 participants
71
(12 to 147)
1.Primary Outcome
Title Number of Participants That Completed All Telemedicine Visits
Hide Description Feasibility will be defined as completion of all telemedicine visits by > 2/3 of enrolled patients (unless treatment discontinued early for toxicity or disease progression).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
12
  80.0%
2.Secondary Outcome
Title Percentage of Participants With Stable PSA Levels at 6 Months as Defined by a <20% Change
Hide Description Percent of patients with 6-month PSA stable 20% change at 6 months as compared to baseline
Time Frame baseline and 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
7
  58.3%
3.Secondary Outcome
Title Adherence With Metformin as Measured by Electronic Pill Adherence Monitoring
Hide Description Adherence with metformin as measured by electronic pill adherence monitoring. Patients were provided with an electronic medication dispenser/medication adherence monitoring device. The device provided audible and visual reminders to proceed with drug dosing and was equipped with a cellular modem that registers a signal to a cloud-based database each time a patient accessed his or her study medication. However, the size and shape of the metformin pills caused the device to malfunction frequently, which led patients to access the pills from the device manually; the data, therefore, could not be used for analysis.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I would participate in a clinical trial in the future".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients did not complete the questionnaire
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
10
  76.9%
Agree
3
  23.1%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
5.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I would participate in a telemedicine clinical trial in the future".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
9
  69.2%
Agree
4
  30.8%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
6.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "The time commitment required for participation in this trial was not overly burdensome".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
11
  84.6%
Agree
2
  15.4%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
7.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "Participation in this trial did not disrupt my work or other activities".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
11
  84.6%
Agree
2
  15.4%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
8.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I found it easy to use the telemonitoring tablet computer".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
5
  38.5%
Agree
2
  15.4%
Neither agree nor disagree
0
   0.0%
Disagree
4
  30.8%
Strongly disagree
2
  15.4%
9.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "This telemedicine approach eases the travel burden for participation in clinical trials for patients".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
10
  76.9%
Agree
3
  23.1%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
10.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "This telemedicine approach eases the financial burden of participation in clinical trials for patients".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
11
  84.6%
Agree
2
  15.4%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
11.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "My local physician was adequately informed about my participation in this trial (if applicable)".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
11
  84.6%
Agree
2
  15.4%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
12.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I felt I was monitored sufficiently closely while enrolled in this trial".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
11
  84.6%
Agree
2
  15.4%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
13.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I would recommend participation in a telemedicine clinical trial to other patients".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
11
  84.6%
Agree
2
  15.4%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
14.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I would participate in a clinical trial where the entire trial was conducted remotely without requiring any visits to the study center".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
8
  61.5%
Agree
3
  23.1%
Neither agree nor disagree
1
   7.7%
Disagree
0
   0.0%
Strongly disagree
1
   7.7%
15.Secondary Outcome
Title Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12
Hide Description Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - "I felt that I was able to communicate well with the study team, even though most contact was through the tablet computer video instead of in person".
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly agree
12
  92.3%
Agree
1
   7.7%
Neither agree nor disagree
0
   0.0%
Disagree
0
   0.0%
Strongly disagree
0
   0.0%
16.Secondary Outcome
Title Urgency to Have a Bowel Movement Episodes
Hide Description Quality of LIfe as measured by a modified RAND 36-Item Health Survey. Ist reported outcome - Number of episodes of urgency to have a bowel movement
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: episodes
No problem 4
Very small problem 4
Small problem 1
Moderate problem 1
Big problem 0
17.Secondary Outcome
Title Increased Frequency of Bowel Movements
Hide Description Quality of LIfe as measured by a modified RAND 36-Item Health Survey. Ist reported outcome - Number of episodes of Increased frequency of bowel movements
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: episodes
No problem 6
Very small problem 3
Small problem 0
Moderate problem 1
Big problem 0
18.Secondary Outcome
Title Episodes of Watery Bowel Movements
Hide Description Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 2st reported outcome - Number of episodes of watery bowel movements
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: episodes
No problem 4
Very small problem 3
Small problem 2
Moderate problem 1
Big problem 0
19.Secondary Outcome
Title Episodes of Flatulence
Hide Description Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 3rd reported outcome - Number of episodes of flatulence
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: episodes
No problem 8
Very small problem 1
Small problem 1
Moderate problem 0
Big problem 0
20.Secondary Outcome
Title Episodes of Bloating
Hide Description Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 4th reported outcome - Number of episodes of bloating
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: episodes
No problem 8
Very small problem 1
Small problem 1
Moderate problem 0
Big problem 0
21.Secondary Outcome
Title Episodes of Nausea
Hide Description Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 5th reported outcome - Number of episodes of nausea
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: episodes
No problem 8
Very small problem 1
Small problem 0
Moderate problem 1
Big problem 0
22.Secondary Outcome
Title Episodes of Vomiting
Hide Description Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 6th reported outcome - Number of episodes of vomiting
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:
850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: episodes
No problem 10
Very small problem 0
Small problem 0
Moderate problem 0
Big problem 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin
Hide Arm/Group Description 850 mg PO once daily for 4 weeks Metformin: 850 mg PO twice daily for 5 months (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
All-Cause Mortality
Metformin
Affected / at Risk (%)
Total   0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin
Affected / at Risk (%) # Events
Total   1/15 (6.67%)    
General disorders   
Dehydration [1]  1/15 (6.67%)  1
[1]
Dehydration from anorexia and nausea requiring hospitalization. Resolved with discontinuation of metformin and intravenous hydration
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin
Affected / at Risk (%) # Events
Total   15/15 (100.00%)    
Gastrointestinal disorders   
Abdominal cramps  1/15 (6.67%) 
Abdominal Pain  1/15 (6.67%) 
Bloating  2/15 (13.33%) 
Consitipation  2/15 (13.33%) 
Diarrhea  12/15 (80.00%) 
Dyspepsia  1/15 (6.67%) 
Flatulence  1/15 (6.67%) 
Indigestion  1/15 (6.67%) 
General disorders   
Anorexia  2/15 (13.33%) 
Fatigue  6/15 (40.00%) 
Nausea  1/15 (6.67%) 
Pain  1/15 (6.67%) 
Queasiness  1/15 (6.67%) 
Vomiting  1/15 (6.67%) 
Weight loss  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
Muscle Weakness  1/15 (6.67%) 
One limitation was the need for a single onsite enrollment visit, which likely still represents a significant geographic barrier to trial accrual.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Matthew D. Galsky
Organization: Icahn School of Medicine at Mount Sinai
Phone: (212) 659-5599
Responsible Party: Matthew Galsky, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02376166     History of Changes
Other Study ID Numbers: GCO 14-0472
First Submitted: February 24, 2015
First Posted: March 3, 2015
Results First Submitted: October 18, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017