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Trial record 44 of 228 for:    metformin and cancer AND Hypoglycemic

Castration Compared to Castration Plus Metformin as First Line Treatment for Patients With Advanced Prostate Cancer

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: NCT01620593
Recruitment Status : Completed
First Posted : June 15, 2012
Results First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Placebo
Drug: Metformin
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo and Castration Metformin and Castration
Hide Arm/Group Description

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

Period Title: Overall Study
Started 21 20
Completed 17 19
Not Completed 4 1
Arm/Group Title Placebo and Castration Metformin and Castration Total
Hide Arm/Group Description

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

Total of all reporting groups
Overall Number of Baseline Participants 17 19 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
19
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 36 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
17
 100.0%
19
 100.0%
36
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 19 participants 36 participants
17
 100.0%
19
 100.0%
36
 100.0%
1.Primary Outcome
Title Metabolic Syndrome
Hide Description Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy:change in weight.
Time Frame Change from 0 weeks to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects that completed the study were analyzed
Arm/Group Title Placebo and Castration Metformin and Castration
Hide Arm/Group Description:

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

Overall Number of Participants Analyzed 17 19
Mean (Full Range)
Unit of Measure: kilograms
0
(0 to 0)
0
(0 to 0)
2.Primary Outcome
Title Metabolic Syndrome Waist Circumference
Hide Description Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy:change in waist circumference.
Time Frame Change from 12 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Castration Metformin and Castration
Hide Arm/Group Description:

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

Overall Number of Participants Analyzed 17 19
Mean (Full Range)
Unit of Measure: centimeters
40.52
(29.5 to 47.5)
41.14
(30.25 to 50.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo and Castration, Metformin and Castration
Comments [Not Specified]
Type of Statistical Test Superiority
Comments t-test
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title PSA Response
Hide Description Complete Response for PSA measure was defined as a PSA less than or equal to 4 ng/ml or undetectable value at 7 months.
Time Frame 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Castration Metformin and Castration
Hide Arm/Group Description:

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: ng/ml
58.2  (193.43) 8.36  (18.35)
4.Secondary Outcome
Title Treatment Failure
Hide Description Progression time from randomization to the earliest disease progression defined as an increase of 20% or more as per RECIST criteria. Patients will not be removed from protocol treatment for PSA progression alone in the first 12 weeks on this study. Further rise in PSA even in the absence of deterioration of pre-existing lesions will constitute treatment failure. Adverse event leading to withdrawal related to metformin or placebo or castration treatment. Death from any cause. Patients unwillingness to continue. Patient's non-compliance with taking the study intervention - 50% or higher.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome was not measured
Arm/Group Title Placebo and Castration Metformin and Castration
Hide Arm/Group Description:

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

The safety and tolerability of metformin with castration therapy as compared to castration therapy alone as measured by the number of subjects experiencing adverse events using CTCAE (common terminology criteria for adverse events) version 4 criteria. Grades are assigned to each adverse event where:

Grade 1 is mild symptoms Grade 2 is moderate symptoms Grade 3 is severe or medically significant but not immediately life-threatening symptoms Grade 4 is life-threatening consequences, where urgent intervention is indicated Grade 5 is death related to the adverse event

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo and Castration Metformin and Castration
Hide Arm/Group Description:

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

Overall Number of Participants Analyzed 17 19
Measure Type: Count of Participants
Unit of Measure: Participants
Greater than or equal to 1 adverse event
0
   0.0%
2
  10.5%
Adverse event leading to treatment dose reduction
0
   0.0%
7
  36.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo and Castration Metformin and Castration
Hide Arm/Group Description

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

All-Cause Mortality
Placebo and Castration Metformin and Castration
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo and Castration Metformin and Castration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo and Castration Metformin and Castration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      8/19 (42.11%)    
Gastrointestinal disorders     
Diarrhea *  1/17 (5.88%)  1 3/19 (15.79%)  3
Nausea *  0/17 (0.00%)  0 3/19 (15.79%)  3
Musculoskeletal and connective tissue disorders     
Muscle Pain *  0/17 (0.00%)  0 1/19 (5.26%)  1
Renal and urinary disorders     
Increased Creatinine *  1/17 (5.88%)  1 1/19 (5.26%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sukeshi Arora, MD
Organization: UT Health San Antonio Cancer Center
Phone: 210-450-1015
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01620593     History of Changes
Other Study ID Numbers: CTRC 10-21
HSC20110273H ( Other Identifier: UTHSCSA IRB )
First Submitted: May 31, 2012
First Posted: June 15, 2012
Results First Submitted: December 14, 2017
Results First Posted: May 22, 2018
Last Update Posted: May 22, 2018