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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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Slow accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Gabapentin | Experimental | 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. |
|
| Arm B: Venlafaxine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of Life | 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 | observed over a 6 month treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups | Toxicity rates will be compared between the two groups | over a 6 month treatment period |
| Assess Changes in the Hot Flash Scores for the Two Arms |
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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
Exclusion Criteria:
cannot currently be taking serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors (MAOIs)
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| Name | Affiliation | Role |
|---|---|---|
| Justine Bruce, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics (Carbone Cancer Center) | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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Subjects were recruited from medical clinic between the dates of 1/31/2012 and 5/9/2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Quality of Life | 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 | Zero participants analyzed due to early termination of study. | Posted | observed over a 6 month treatment period |
|
Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Systolic Ejection Murmur | Cardiac disorders | Systematic Assessment |
The study was terminated due to slow accrual. The data was uninterpretable due to the small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Justine Bruce | University of Wisconsin Carbone Cancer Center | 608-263-7107 | jybruce@medicine.wisc.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
| Venlafaxine | Drug | 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. |
|
|
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
| 6 month treatment period |
| Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS) | 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. | over the 6 month treatment period |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
|
| Secondary | Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups | Toxicity rates will be compared between the two groups | Zero participants analyzed due to early termination of study | Posted | over a 6 month treatment period |
|
|
| Secondary | Assess Changes in the Hot Flash Scores for the Two Arms | 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 | Zero participants analyzed due to early termination of study | Posted | 6 month treatment period |
|
|
| Secondary | Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS) | 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. | Zero participants analyzed due to early termination of study | Posted | over the 6 month treatment period |
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | 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. 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. | 0 | 3 | 2 | 3 |
| Pain | General disorders | Non-systematic Assessment |
|
| Balance problem | Nervous system disorders | Non-systematic Assessment |
|
| Vivid Dreams | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders |
|
| vertigo | Ear and labyrinth disorders |
|
| Urinary Tract Infection | Infections and infestations |
|
| Urinary Frequency | Renal and urinary disorders |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D008055 | Lipids |