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

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Gabapentin; Drug: Venlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT01533753

CO11813

NCI-2012-00050 (Registry Identifier)

SMPH/MEDICINE/MEDICINE*H (Other Identifier)

2011-0492 (Other Identifier)

A534260 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

5 participants in 2 patient groups

Arm A: Gabapentin

Experimental 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.

Treatment:

Drug: Gabapentin

Arm B: Venlafaxine

Experimental group

Description:

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.

Treatment:

Drug: Venlafaxine