Prostate Cancer
Conditions
Keywords
hot flashes, prostate cancer
Brief summary
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.
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.
Interventions
DRUGGabapentin
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.
DRUGVenlafaxine
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Quality of Life | 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
| Measure | Time frame | Description |
|---|---|---|
| Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups | 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 | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from medical clinic between the dates of 1/31/2012 and 5/9/2014.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Arm A: Gabapentin | Arm B: Venlafaxine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized African American | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 1 participants | 3 participants | 4 participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 2 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
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
Time frame: observed over a 6 month treatment period
Population: Zero participants analyzed due to early termination of study.
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.
Time frame: over the 6 month treatment period
Population: Zero participants analyzed due to early termination of study
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
Time frame: 6 month treatment period
Population: Zero participants analyzed due to early termination of study
Secondary
Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups
Toxicity rates will be compared between the two groups
Time frame: over a 6 month treatment period
Population: Zero participants analyzed due to early termination of study