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

November 13, 2019 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: 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.
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:
  • Gralise
  • Neurontin
  • Gabarone
  • Fanatrex
  • Horizant
Experimental: Arm B: Venlafaxine
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.
Drug: Venlafaxine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Quality of Life
Time Frame: observed over a 6 month treatment period
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
observed over a 6 month treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups
Time Frame: over a 6 month treatment period
Toxicity rates will be compared between the two groups
over a 6 month treatment period
Assess Changes in the Hot Flash Scores for the Two Arms
Time Frame: 6 month treatment period
Assess percentage changes in the hot flash score from baseline to cycle 6 between gabapentin and venlafaxine in men with prostate cancer treated with for hot flashes related to androgen deprivation therapy
6 month treatment period
Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)
Time Frame: over the 6 month treatment period
Assess percent change in quality of life from baseline to cycle 6, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.
over the 6 month treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 15, 2012

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO11813
  • A534260 (Other Identifier: UW Madison)
  • SMPH/MEDICINE/MEDICINE*H (Other Identifier: UW Madison)
  • 2011-0492 (Other Identifier: Institutional Review Board)
  • NCI-2012-00050 (Registry Identifier: NCI Trial ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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