Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00028574|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Hot Flashes Prostate Cancer||Drug: gabapentin Other: placebo||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||223 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men|
|Study Start Date :||December 2001|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||April 2007|
Active Comparator: Gabapentin (28 days)
Oral Gabapentin 300 mg days 1-28
Active Comparator: Gabapentin (7, 21)
Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28
Active Comparator: Gabapentin (7, 7, 14)
Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
Placebo Comparator: Placebo
Oral Placebo 300 mg on one of the following schedules:
- Hot flash reduction by diary scores at 4 weeks [ Time Frame: 5 weeks from study entry ]
- Toxicity by questionnaires at 4 weeks [ Time Frame: 5 weeks from study entry ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028574
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|Study Chair:||Charles Loprinzi, MD||Mayo Clinic|