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

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
Prostate Cancer	Drug: Gabapentin Drug: Venlafaxine	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

Drug Information available for: Gabapentin Venlafaxine Venlafaxine hydrochloride Gabapentin enacarbil

U.S. FDA Resources

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 ]
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 ]
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 ]
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 ]
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.


Enrollment:	5
Study Start Date:	February 2012
Study Completion Date:	May 2014
Primary Completion Date:	January 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 (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533753

Locations


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

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators


Principal Investigator:	Justine Bruce, MD	University of Wisconsin, Madison

More Information


Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT01533753 History of Changes
Other Study ID Numbers:	CO11813
Study First Received:	February 10, 2012
Results First Received:	August 25, 2014
Last Updated:	September 10, 2014

Keywords provided by University of Wisconsin, Madison:


hot flashes prostate cancer

Additional relevant MeSH terms:


Prostatic Neoplasms Hot Flashes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Signs and Symptoms Gabapentin Venlafaxine Hydrochloride gamma-Aminobutyric Acid Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents

ClinicalTrials.gov processed this record on June 26, 2017