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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01533753
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 26.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Gabapentin; Drug: Venlafaxine	Phase 2

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.

Study Design

• Study Type: Interventional
• 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: Feb 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

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.	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 Names: Effexor

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Wisconsin Carbone Cancer Center

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01533753
• Other Study ID Numbers: CO11813; 2011-0492; A534260; SMPH/MEDICINE/MEDICINE*H; NCI-2012-00050
• First Posted: Feb 15, 2012
• Last Update Posted: Nov 21, 2019
• Last Verified: Sep 1, 2014

• Keywords provided by University of Wisconsin, Madison: hot flashes; prostate cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Hot Flashes; Gabapentin; Venlafaxine Hydrochloride

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from medical clinic between the dates of 1/31/2012 and 5/9/2014.

Arm/Group Title	Arm A: Gabapentin	Arm B: Venlafaxine
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	2	3
COMPLETED	2	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm A: Gabapentin	Arm B: Venlafaxine	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	2	3	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	1 33.3%	1 20%
>=65 years	2 100%	2 66.7%	4 80%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	2 100%	3 100%	5 100%
Race/Ethnicity, Customized (participants) [Number]
White	1 50%	3 100%	4 80%
African American	1 50%	0 0%	1 20%
Region of Enrollment (participants) [Number]
United States	2 100%	3 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

Zero participants analyzed due to early termination of study.

Arm/Group Title	Arm A: Gabapentin	Arm B: Venlafaxine
Arm/Group Description	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.	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.
Measure Participants	0	0

2. Secondary Outcome

Title	Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups
Description	Toxicity rates will be compared between the two groups
Time Frame	over a 6 month treatment period

Outcome Measure Data

Analysis Population Description

Zero participants analyzed due to early termination of study

Arm/Group Title	Arm A: Gabapentin	Arm B: Venlafaxine
Arm/Group Description	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.	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.
Measure Participants	0	0

3. Secondary Outcome

Title	Assess Changes in the Hot Flash Scores for the Two Arms
Description	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

Outcome Measure Data

Analysis Population Description

Zero participants analyzed due to early termination of study

Arm/Group Title	Arm A: Gabapentin	Arm B: Venlafaxine
Arm/Group Description	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.	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.
Measure Participants	0	0

4. Secondary Outcome

Title	Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)
Description	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

Outcome Measure Data

Analysis Population Description

Zero participants analyzed due to early termination of study

Arm/Group Title	Arm A: Gabapentin	Arm B: Venlafaxine
Arm/Group Description	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.	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.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Arm/Group Title	Arm A: Gabapentin		Arm B: Venlafaxine
Arm/Group Description	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.		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.
All Cause Mortality
	Arm A: Gabapentin		Arm B: Venlafaxine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A: Gabapentin		Arm B: Venlafaxine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Arm A: Gabapentin		Arm B: Venlafaxine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		2/3 (66.7%)
Cardiac disorders
Systolic Ejection Murmur	1/2 (50%)	1	0/3 (0%)	0
Ear and labyrinth disorders
vertigo	1/2 (50%)	1	0/3 (0%)	0
Gastrointestinal disorders
Nausea	0/2 (0%)	0	1/3 (33.3%)	1
General disorders
Pain	1/2 (50%)	2	1/3 (33.3%)	1
Infections and infestations
Urinary Tract Infection	1/2 (50%)	1	0/3 (0%)	0
Nervous system disorders
Balance problem	1/2 (50%)	1	0/3 (0%)	0
Vivid Dreams	0/2 (0%)	0	1/3 (33.3%)	1
Psychiatric disorders
Insomnia	0/2 (0%)	0	1/3 (33.3%)	1
Renal and urinary disorders
Urinary Frequency	1/2 (50%)	1	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
Sore Throat	1/2 (50%)	1	0/3 (0%)	0
Cough	1/2 (50%)	1	0/3 (0%)	0

Limitations/Caveats

The study was terminated due to slow accrual. The data was uninterpretable due to the small numbers of subjects analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.