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

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01533753
First received: February 10, 2012
Last updated: September 10, 2014
Last verified: September 2014

February 10, 2012
September 10, 2014
February 2012
January 2014   (final data collection date for primary outcome measure)
Changes 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
Same as current
Complete list of historical versions of study NCT01533753 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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:
    • 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 Name: Effexor
  • 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.
    Intervention: Drug: Gabapentin
  • 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.
    Intervention: Drug: Venlafaxine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
May 2014
January 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01533753
CO11813
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Justine Bruce, MD University of Wisconsin, Madison
University of Wisconsin, Madison
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP