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

This study is currently recruiting participants.
Verified May 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01533753
First received: February 10, 2012
Last updated: May 20, 2013
Last verified: May 2013
  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.


Condition Intervention Phase
Hot Flashes in Men With Prostate Cancer Receiving Androgen Ablation Therapy
Drug: Gabapentin
Drug: Venlafaxine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open-Label Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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


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.


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533753

Contacts
Contact: UWCCC Cancer Connect 1-800-622-8922

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics (Carbone Cancer Center) Recruiting
Madison, Wisconsin, United States, 53792
Contact: UWCCC Cancer Connect    800-622-8922      
Sub-Investigator: Jane Straus, BSN         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Justine Bruce, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01533753     History of Changes
Other Study ID Numbers: CO11813
Study First Received: February 10, 2012
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
hot flashes
prostate cancer

Additional relevant MeSH terms:
Hot Flashes
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms
Gabapentin
Venlafaxine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on April 17, 2014