Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett Esophagus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01447927
First received: October 5, 2011
Last updated: June 19, 2014
Last verified: June 2014
Results First Received: April 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Barrett Esophagus
Esophageal Cancer
Interventions: Drug: metformin hydrochloride
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Ninety-three subjects were pre-registered through 12 Cancer Prevention Network (CPN) member organizations from February 2012 and January 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject withdrew post-randomization and did not receive any treatment and 18 subjects were excluded from the trial before assignment to groups: 8 out of range lab values, 4 high grade dysplasia/esophagitis/esophageal stricture, 2 intestinal metaplasia on <25% of biopsies, and 4 other reasons.

Reporting Groups
  Description
Metformin Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD) on week 1, and twice daily (BID) on weeks 2-12 (every morning (QAM) every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
Placebo Patients receive extended-release placebo orally (PO) once daily (QD) on week 1and BID on weeks 2-12 (every morning (QAM) and every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.

Participant Flow:   Overall Study
    Metformin     Placebo  
STARTED     38     36  
COMPLETED     33     33  
NOT COMPLETED     5     3  
Adverse Event                 4                 3  
Withdrawal by Subject                 1                 0  



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

Reporting Groups
  Description
Metformin Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
Placebo Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
Total Total of all reporting groups

Baseline Measures
    Metformin     Placebo     Total  
Number of Participants  
[units: participants]
  38     36     74  
Age  
[units: years]
Median ( Full Range )
  60.5  
  ( 20.0 to 81.0 )  
  60.5  
  ( 39.0 to 79.0 )  
  60.5  
  ( 20.0 to 81.0 )  
Gender  
[units: participants]
     
Female     8     8     16  
Male     30     28     58  
Performance Score [1]
[units: participants]
     
0-Fully active     37     35     72  
1-Ambulatory, restricted strenuous activity     1     1     2  
Body Mass Index  
[units: kg/m^2]
Median ( Full Range )
  30.1  
  ( 22.3 to 44.5 )  
  29.9  
  ( 20.2 to 52.0 )  
  30.0  
  ( 20.2 to 52.0 )  
Length of Barrett's segment  
[units: participants]
     
<5 cm of circumferential involvement     11     11     22  
>=5 cm of circumferential involvement     27     25     52  
Non-steroidal anti-inflammatory drug (NSAID) use  
[units: participants]
     
Regular Use     9     8     17  
No Regular Use     29     28     57  
[1] Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).



  Outcome Measures
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1.  Primary:   Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus   [ Time Frame: Baseline to 3 months ]

2.  Secondary:   Overall Adverse Event Rates   [ Time Frame: Up to 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Amitabh Chak
Organization: University Hospitals of Cleveland, Case Medical Center
phone: 216-844-5385
e-mail: Amitabh.chak@case.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01447927     History of Changes
Other Study ID Numbers: NCI-2011-03451, MAY10-15-03, MAYO-MAY10-15-03, CDR0000698069
Study First Received: October 5, 2011
Results First Received: April 2, 2014
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration