Trials / Completed
CompletedNCT00022074
Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
Control of Vasomotor Symptoms in Women Treated for Breast Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Gary Morrow · Academic / Other
- Sex
- Female
- Age
- 120 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes. PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.
Detailed description
OBJECTIVES: * Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer. * Compare quality of life, anxiety, and depression in patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms. * Arm I: Patients receive oral placebo 3 times a day. * Arm II: Patients receive oral gabapentin at a low dose 3 times a day. * Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day. Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians. Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study. Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8. Patients are followed at week 12. PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gabapentin | |
| PROCEDURE | quality-of-life assessment |
Timeline
- Start date
- 2001-07-01
- Primary completion
- 2005-06-01
- Completion
- 2005-06-01
- First posted
- 2003-01-27
- Last updated
- 2015-10-15
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00022074. Inclusion in this directory is not an endorsement.