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

NCT01533753 | Terminated Phase 2 Results

• 5 other identifiers: CO118132011-0492A534260SMPH/MEDICINE/MEDICINE*HNCI-2012-00050
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

hot flashes; prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups

  over a 6 month treatment period

• Assess Changes in the Hot Flash Scores for the Two Arms

  6 month treatment period

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

  over the 6 month treatment period

Study Arms (2)

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.

Drug: Gabapentin

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.

Drug: Venlafaxine

Interventions

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.

Also known as: Fanatrex, Gabarone, Gralise, Horizant, Neurontin

Arm A: Gabapentin

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.

Also known as: Effexor

Arm B: Venlafaxine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics (Carbone Cancer Center)

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms; Hot Flashes

Interventions

Gabapentin; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Lipids

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Justine Bruce
• Organization: University of Wisconsin Carbone Cancer Center

jybruce@medicine.wisc.edu

608-263-7107

Study Officials

• Justine Bruce, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 21, 2019
• Results First Posted: September 15, 2014

Record last verified: 2014-09

Locations

US (1)