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

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ClinicalTrials.gov Identifier: NCT01533753
Recruitment Status : Terminated (Slow accrual)
First Posted : February 15, 2012
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Gabapentin
Drug: Venlafaxine
Enrollment 5
Recruitment Details Subjects were recruited from medical clinic between the dates of 1/31/2012 and 5/9/2014.
Pre-assignment Details  
Arm/Group Title Arm A: Gabapentin Arm B: Venlafaxine
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 2 3
Completed 2 3
Not Completed 0 0
Arm/Group Title Arm A: Gabapentin Arm B: Venlafaxine Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
1
  33.3%
1
  20.0%
>=65 years
2
 100.0%
2
  66.7%
4
  80.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
3
 100.0%
5
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
White 1 3 4
African American 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
1.Primary Outcome
Title Changes in Quality of Life
Hide Description We will measure the absolute change in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy
Time Frame observed over a 6 month treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed due to early termination of study.
Arm/Group Title Arm A: Gabapentin Arm B: Venlafaxine
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups
Hide Description Toxicity rates will be compared between the two groups
Time Frame over a 6 month treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed due to early termination of study
Arm/Group Title Arm A: Gabapentin Arm B: Venlafaxine
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Assess Changes in the Hot Flash Scores for the Two Arms
Hide Description Assess percentage changes in the hot flash score from baseline to cycle 6 between gabapentin and venlafaxine in men with prostate cancer treated with for hot flashes related to androgen deprivation therapy
Time Frame 6 month treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed due to early termination of study
Arm/Group Title Arm A: Gabapentin Arm B: Venlafaxine
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)
Hide Description Assess percent change in quality of life from baseline to cycle 6, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.
Time Frame over the 6 month treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed due to early termination of study
Arm/Group Title Arm A: Gabapentin Arm B: Venlafaxine
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: Gabapentin Arm B: Venlafaxine
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Arm A: Gabapentin Arm B: Venlafaxine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Gabapentin Arm B: Venlafaxine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Gabapentin Arm B: Venlafaxine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      2/3 (66.67%)    
Cardiac disorders     
Systolic Ejection Murmur   1/2 (50.00%)  1 0/3 (0.00%)  0
Ear and labyrinth disorders     
vertigo  1/2 (50.00%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Nausea  0/2 (0.00%)  0 1/3 (33.33%)  1
General disorders     
Pain *  1/2 (50.00%)  2 1/3 (33.33%)  1
Infections and infestations     
Urinary Tract Infection  1/2 (50.00%)  1 0/3 (0.00%)  0
Nervous system disorders     
Balance problem *  1/2 (50.00%)  1 0/3 (0.00%)  0
Vivid Dreams *  0/2 (0.00%)  0 1/3 (33.33%)  1
Psychiatric disorders     
Insomnia  0/2 (0.00%)  0 1/3 (33.33%)  1
Renal and urinary disorders     
Urinary Frequency  1/2 (50.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Sore Throat  1/2 (50.00%)  1 0/3 (0.00%)  0
Cough  1/2 (50.00%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
The study was terminated due to slow accrual. The data was uninterpretable due to the small numbers of subjects analyzed.
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
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01533753     History of Changes
Other Study ID Numbers: CO11813
First Submitted: February 10, 2012
First Posted: February 15, 2012
Results First Submitted: August 25, 2014
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014