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:
University of Wisconsin, Madison
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
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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:
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 ] [ 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:
|
|
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 June 13, 2013