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

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Venlafaxine Hydrochloride

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.