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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Hot Flashes in Men With Prostate Cancer Receiving Androgen Ablation Therapy

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Changes in quality of life

Outcome Description:

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

Outcome Time Frame:

observed over a 6 month treatment period

Safety Issue:

No

Principal Investigator

Justine Bruce, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

CO11813

NCT ID:

NCT01533753

Start Date:

February 2012

Completion Date:

August 2014

Related Keywords:

  • Hot Flashes in Men With Prostate Cancer Receiving Androgen Ablation Therapy
  • hot flashes
  • prostate cancer
  • Prostatic Neoplasms
  • Hot Flashes

Name

Location

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