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

Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Gabapentin (Drug); Venlafaxine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Justine Bruce, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison

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.

Clinical Details

Official title: Randomized, Open-Label Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes in Quality of Life

Secondary outcome:

Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups

Assess Changes in the Hot Flash Scores for the Two Arms

Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Locations and Contacts

University of Wisconsin Hospital and Clinics (Carbone Cancer Center), Madison, Wisconsin 53792, United States
Additional Information

Starting date: February 2012
Last updated: September 10, 2014

Page last updated: August 23, 2015

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