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

Prostate Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Prostate Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:GabapentinGabapentin 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.

Drug:VenlafaxineVenlafaxine 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm A: GabapentinGabapentin 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: VenlafaxineVenlafaxine 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.

Study Status

Terminated

Start Date: February 2012

Completed Date: May 2014

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Changes in Quality of Life

Secondary Outcome: Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups

Study sponsors, principal investigator, and references

Principal Investigator: Justine Bruce, MD

Lead Sponsor: University of Wisconsin, Madison

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01533753

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