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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionHot Flashes in Men With Prostate Cancer Receiving Androgen Ablation Therapy
InterventionDrug: Gabapentin
Drug: Venlafaxine
PhasePhase 2
SponsorUniversity of Wisconsin, Madison
Responsible PartyUniversity of Wisconsin, Madison
ClinicalTrials.gov IdentifierNCT01533753
First ReceivedFebruary 10, 2012
Last UpdatedMay 20, 2013
Last verifiedMay 2013

Tracking Information[ + expand ][ + ]

First Received DateFebruary 10, 2012
Last Updated DateMay 20, 2013
Start DateFebruary 2012
Estimated Primary Completion DateAugust 2014
Current Primary Outcome MeasuresChanges in quality of life [Time Frame: observed over a 6 month treatment period] [Designated as safety issue: No]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
Current Secondary Outcome Measures
  • compare toxicity rates between the gabapentin and venlafaxine treatment groups [Time Frame: over a 6 month treatment period] [Designated as safety issue: Yes]Toxicity rates will be compared between the two groups
  • Assess changes in the hot flash scores for the two arms [Time Frame: 6 month treatment period] [Designated as safety issue: No]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
  • Assess changes in quality of life using the Hot flash related Daily Interference Scale (HFRDIS) [Time Frame: over the 6 month treatment period] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief TitleQuality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Official TitleRandomized, Open-Label Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Brief 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.
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 TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHot Flashes in Men With Prostate Cancer Receiving Androgen Ablation Therapy
InterventionDrug: 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:
  • Fanatrex
  • Gabarone
  • Gralise
  • Horizant
  • Neurontin
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
Study Arm (s)
  • 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.
  • 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment60
Estimated Completion DateAugust 2014
Estimated Primary Completion DateJune 2014
Eligibility 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.
GenderMale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: UWCCC Cancer Connect
1-800-622-8922
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01533753
Other Study ID NumbersCO11813
Has Data Monitoring CommitteeNot Provided
Information Provided ByUniversity of Wisconsin, Madison
Study SponsorUniversity of Wisconsin, Madison
CollaboratorsNot Provided
Investigators Principal Investigator: Justine Bruce, MD University of Wisconsin, Madison
Verification DateMay 2013

Locations[ + expand ][ + ]

University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
Madison, Wisconsin, United States, 53792
Contact: UWCCC Cancer Connect | 800-622-8922
Sub-Investigator: Jane Straus, BSN
Recruiting