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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Venlafaxine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Fanatrex Gabarone Gralise Horizant Neurontin Effexor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No