Trial Outcomes & Findings for Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer (NCT NCT01533753)

Last Updated: 2019-11-21

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

observed over a 6 month treatment period

Results posted on

2019-11-21

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	2	3
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Gabapentin n=2 Participants 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.	Arm B: Venlafaxine n=3 Participants 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 n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized African American	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: observed over a 6 month treatment period

Population: Zero participants analyzed due to early termination of study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: over a 6 month treatment period

Population: Zero participants analyzed due to early termination of study

Toxicity rates will be compared between the two groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month treatment period

Population: Zero participants analyzed due to early termination of study

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: over the 6 month treatment period

Population: Zero participants analyzed due to early termination of study

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.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: Gabapentin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm B: Venlafaxine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm A: Gabapentin n=2 participants at risk 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.	Arm B: Venlafaxine n=3 participants at risk 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.
Infections and infestations Urinary Tract Infection	50.0% 1/2 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	0.00% 0/3 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Cardiac disorders Systolic Ejection Murmur	50.0% 1/2 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	0.00% 0/3 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
General disorders Pain	50.0% 1/2 • Number of events 2 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Nervous system disorders Balance problem	50.0% 1/2 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	0.00% 0/3 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Nervous system disorders Vivid Dreams	0.00% 0/2 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Psychiatric disorders Insomnia	0.00% 0/2 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Ear and labyrinth disorders vertigo	50.0% 1/2 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	0.00% 0/3 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Renal and urinary disorders Urinary Frequency	50.0% 1/2 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	0.00% 0/3 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Respiratory, thoracic and mediastinal disorders Sore Throat	50.0% 1/2 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	0.00% 0/3 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	33.3% 1/3 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Number of events 1 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment	0.00% 0/3 • Adverse event data was collected from the time of first dose of treatment through 6 months of treatment

Additional Information

Dr. Justine Bruce

University of Wisconsin Carbone Cancer Center

Phone: 608-263-7107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place