Clinical trial NCT01533753: Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Official title: Randomized, Open-Label Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: hot flashes
prostate cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in Quality of Life
timeFrame: observed over a 6 month treatment period
Secondary outcomes:
measure: Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups
timeFrame: over a 6 month treatment period
measure: Assess Changes in the Hot Flash Scores for the Two Arms
timeFrame: 6 month treatment period
measure: Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: over the 6 month treatment period
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Justine Bruce, MD
role: PRINCIPAL_INVESTIGATOR
References: