Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01533753
First received: February 10, 2012
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: August 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Gabapentin
Drug: Venlafaxine

  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
Subjects were recruited from medical clinic between the dates of 1/31/2012 and 5/9/2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A: Gabapentin

Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.

Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.

Arm B: Venlafaxine

Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.

Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.


Participant Flow:   Overall Study
    Arm A: Gabapentin     Arm B: Venlafaxine  
STARTED     2     3  
COMPLETED     2     3  
NOT COMPLETED     0     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
Arm A: Gabapentin

Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.

Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.

Arm B: Venlafaxine

Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.

Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.

Total Total of all reporting groups

Baseline Measures
    Arm A: Gabapentin     Arm B: Venlafaxine     Total  
Number of Participants  
[units: participants]
  2     3     5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     1     1  
>=65 years     2     2     4  
Gender  
[units: participants]
     
Female     0     0     0  
Male     2     3     5  
Race/Ethnicity, Customized  
[units: participants]
     
White     1     3     4  
African American     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     2     3     5  



  Outcome Measures
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1.  Primary:   Changes in Quality of Life   [ Time Frame: observed over a 6 month treatment period ]

2.  Secondary:   Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups   [ Time Frame: over a 6 month treatment period ]

3.  Secondary:   Assess Changes in the Hot Flash Scores for the Two Arms   [ Time Frame: 6 month treatment period ]

4.  Secondary:   Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)   [ Time Frame: over the 6 month treatment period ]


  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
The study was terminated due to slow accrual. The data was uninterpretable due to the small numbers of subjects analyzed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Justine Bruce
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-263-7107
e-mail: jybruce@medicine.wisc.edu


No publications provided


Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01533753     History of Changes
Other Study ID Numbers: CO11813
Study First Received: February 10, 2012
Results First Received: August 25, 2014
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration