Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087399
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2004-07-08
Brief Title:
Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Randomized Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone
Status:
COMPLETED
Status Verified Date:
2016-07
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 in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes
PURPOSE This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes
PURPOSE This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes
Detailed Description:
OBJECTIVES
Compare the efficacy of gabapentin with vs without an antidepressant as measured by the frequency and intensity of hot flashes in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer
Compare adverse events in patients treated with these regimens
Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to duration of hot flash symptoms 9 months vs 9 months average frequency of hot flashes per day 2-3 vs 4-9 vs 10 and antidepressant currently being used venlafaxine vs paroxetine vs other Patients are randomized to 1 of 2 treatment arms
Arm I Patients continue to receive the same antidepressant as before study entry on weeks 1-5 During weeks 2-5 patients also receive oral gabapentin once daily on days 8-10 twice daily on days 11-13 and then three times daily on days 14-35 in the absence of unacceptable toxicity
Arm II Patients receive gabapentin as in arm I Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone per arm I schedule
Patients in both arms complete a hot flash diary at baseline and then daily during study treatment
Quality of life is assessed at baseline and then weekly during study treatment
PROJECTED ACCRUAL A total of 110 patients 55 per treatment arm will be accrued for this study within 2 years
Compare the efficacy of gabapentin with vs without an antidepressant as measured by the frequency and intensity of hot flashes in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer
Compare adverse events in patients treated with these regimens
Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to duration of hot flash symptoms 9 months vs 9 months average frequency of hot flashes per day 2-3 vs 4-9 vs 10 and antidepressant currently being used venlafaxine vs paroxetine vs other Patients are randomized to 1 of 2 treatment arms
Arm I Patients continue to receive the same antidepressant as before study entry on weeks 1-5 During weeks 2-5 patients also receive oral gabapentin once daily on days 8-10 twice daily on days 11-13 and then three times daily on days 14-35 in the absence of unacceptable toxicity
Arm II Patients receive gabapentin as in arm I Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone per arm I schedule
Patients in both arms complete a hot flash diary at baseline and then daily during study treatment
Quality of life is assessed at baseline and then weekly during study treatment
PROJECTED ACCRUAL A total of 110 patients 55 per treatment arm will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000374993 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02616 | REGISTRY | None | None |