Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
- Registration Number
- NCT00028574
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes.
PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer.
- Detailed Description
OBJECTIVES:
* Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer.
* Determine the response of patients to this drug.
* Determine the toxicity of this drug in these patients.
* Determine the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms.
All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information.
* Arm I: Patients receive oral gabapentin once daily on days 1-28.
* Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28.
* Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days 8-14, and three times daily on days 15-28.
* Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms I-III.
Patients in all arms may continue therapy with gabapentin for an additional 8 weeks.
Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks.
Patients are followed at 6, 12, and 24 months.
PROJECTED ACCRUAL: A total of 220 patients (55 per treatment arm) will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 223
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gabapentin (7, 21) gabapentin Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28 Placebo placebo Oral Placebo 300 mg on one of the following schedules: * once daily on days 1-28 * once daily on days 1-7, twice daily on days 8-28 * once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28 Gabapentin (28 days) gabapentin Oral Gabapentin 300 mg days 1-28 Gabapentin (7, 7, 14) gabapentin Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
- Primary Outcome Measures
Name Time Method Hot flash reduction by diary scores at 4 weeks 5 weeks from study entry
- Secondary Outcome Measures
Name Time Method Toxicity by questionnaires at 4 weeks 5 weeks from study entry
Trial Locations
- Locations (165)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Howard University Cancer Center at Howard University Hospital
🇺🇸Washington, District of Columbia, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Kapiolani Medical Center at Pali Momi
🇺🇸Aiea, Hawaii, United States
Leeward Radiation Oncology Center
🇺🇸Ewa Beach, Hawaii, United States
Cancer Research Center of Hawaii
🇺🇸Honolula, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸Honolulu, Hawaii, United States
Scroll for more (155 remaining)Mobile Infirmary Medical Center🇺🇸Mobile, Alabama, United States