Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Hot Flashes in Men With Prostate Cancer Receiving Androgen Ablation Therapy |
Intervention | Drug: Gabapentin Drug: Venlafaxine |
Phase | Phase 2 |
Sponsor | University of Wisconsin, Madison |
Responsible Party | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier | NCT01533753 |
First Received | February 10, 2012 |
Last Updated | May 20, 2013 |
Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | February 10, 2012 |
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Last Updated Date | May 20, 2013 |
Start Date | February 2012 |
Estimated Primary Completion Date | August 2014 |
Current Primary Outcome Measures | Changes in quality of life [Time Frame: observed over a 6 month treatment period] [Designated as safety issue: No]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 |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer |
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Official Title | Randomized, Open-Label Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer |
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. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Hot Flashes in Men With Prostate Cancer Receiving Androgen Ablation Therapy |
Intervention | Drug: 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. Other Names:
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. Other Names: Effexor |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 60 |
Estimated Completion Date | August 2014 |
Estimated Primary Completion Date | June 2014 |
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. |
Gender | Male |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: UWCCC Cancer Connect 1-800-622-8922 |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01533753 |
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Other Study ID Numbers | CO11813 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | University of Wisconsin, Madison |
Study Sponsor | University of Wisconsin, Madison |
Collaborators | Not Provided |
Investigators | Principal Investigator: Justine Bruce, MD University of Wisconsin, Madison |
Verification Date | May 2013 |
Locations[ + expand ][ + ]
University of Wisconsin Hospital and Clinics (Carbone Cancer Center) | Madison, Wisconsin, United States, 53792 Contact: UWCCC Cancer Connect | 800-622-8922Sub-Investigator: Jane Straus, BSN Recruiting |
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