Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01533753 |
Recruitment Status :
Terminated
(Slow accrual)
First Posted : February 15, 2012
Results First Posted : September 15, 2014
Last Update Posted : November 21, 2019
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Drug: Gabapentin Drug: Venlafaxine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
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.
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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:
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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.
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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 |
- 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
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men 18 years or older with histologically proven adenocarcinoma of the prostate
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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:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533753
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics (Carbone Cancer Center) | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Justine Bruce, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT01533753 |
Other Study ID Numbers: |
CO11813 2011-0492 ( Other Identifier: Institutional Review Board ) A534260 ( Other Identifier: UW Madison ) SMPH/MEDICINE/MEDICINE*H ( Other Identifier: UW Madison ) NCI-2012-00050 ( Registry Identifier: NCI Trial ID ) |
First Posted: | February 15, 2012 Key Record Dates |
Results First Posted: | September 15, 2014 |
Last Update Posted: | November 21, 2019 |
Last Verified: | September 2014 |
hot flashes prostate cancer |
Prostatic Neoplasms Hot Flashes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Gabapentin Venlafaxine Hydrochloride Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants |
Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Antidepressive Agents, Second-Generation Antidepressive Agents |