Overview

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.