Back to resultsQuality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Venlafaxine
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring hot flashes, prostate cancer
Eligibility Criteria
Inclusion Criteria:
- Men 18 years or older with histologically proven adenocarcinoma of the prostate
Prior or current androgen deprivation for at least 6 months prior to study entry with either bilateral orchiectomy or being maintained on a stable dose of LHRH (luteinizing hormone-releasing hormone) agonist or antagonist
- Hot flash frequency of an average of 2 or more per day (average of 14 hot flash episodes per week)
Exclusion Criteria:
cannot currently be taking serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors (MAOIs)
- cannot have uncontrolled hypertension
- cannot have history of past or current of epilepsy, epilepsy syndrome or other seizure disorder
- cannot have psychiatric history of mania, hypomania, bipolar disorder or anorexia nervosa
- cannot be receiving concurrent treatment with amy medications or herbal products being used with the express purpose of treating hot flashes.
Sites / Locations
- University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A: Gabapentin
Arm B: Venlafaxine
Arm 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.
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.
Outcomes
Primary Outcome Measures
Changes in Quality of Life
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
Secondary Outcome Measures
Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups
Toxicity rates will be compared between the two groups
Assess Changes in the Hot Flash Scores for the Two Arms
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
Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)
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.
Full Information
NCT ID
NCT01533753
First Posted
February 10, 2012
Last Updated
November 13, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01533753
Brief Title
Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Official Title
Randomized, Open-Label Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the change in quality of life over a 6 month period between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.
Detailed Description
60 evaluable patients with prostate cancer currently receiving androgen ablation therapy or who have had an orchiectomy will be enrolled in this study. All patients will be randomized 1:1 (30 patients per treatment arm) to either receive gabapentin or venlafaxine. Treatment duration will be a total of 6 months. During those 6 months, study staff will evaluate frequency and intensity of hot flashes using hot flash score from hot flash diary every 28 days. Patients will also record side effects associated with either gabapentin or venlafaxine on their medication diaries. Study staff will record the severity of all adverse events reported. Patients will also complete the quality of life Functional Assessment of Cancer Therapy-Prostate (FACT-P) form at baseline, cycle 3, and cycle 6/off study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
hot flashes, prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Gabapentin
Arm Type
Experimental
Arm 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.
Arm Title
Arm B: Venlafaxine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Fanatrex, Gabarone, Gralise, Horizant, Neurontin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Other Intervention Name(s)
Effexor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Quality of Life
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
Secondary Outcome Measure Information:
Title
Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups
Description
Toxicity rates will be compared between the two groups
Time Frame
over a 6 month treatment period
Title
Assess Changes in the Hot Flash Scores for the Two Arms
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
Title
Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men 18 years or older with histologically proven adenocarcinoma of the prostate
Prior or current androgen deprivation for at least 6 months prior to study entry with either bilateral orchiectomy or being maintained on a stable dose of LHRH (luteinizing hormone-releasing hormone) agonist or antagonist
Hot flash frequency of an average of 2 or more per day (average of 14 hot flash episodes per week)
Exclusion Criteria:
cannot currently be taking serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors (MAOIs)
cannot have uncontrolled hypertension
cannot have history of past or current of epilepsy, epilepsy syndrome or other seizure disorder
cannot have psychiatric history of mania, hypomania, bipolar disorder or anorexia nervosa
cannot be receiving concurrent treatment with amy medications or herbal products being used with the express purpose of treating hot flashes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justine Bruce, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
We'll reach out to this number within 24 hrs