Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022074
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2001-08-10
Brief Title:
Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
Control of Vasomotor Symptoms in Women Treated for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P01-0183 | None | None | None |
| URCC-U2101 | None | None | None |