Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084669
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2004-06-10
Brief Title:
Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction
Status:
COMPLETED
Status Verified Date:
2010-04
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 Venlafaxine may be effective in relieving hot flashes caused by hormone therapy Giving venlafaxine with zolpidem a sleeping pill may improve sleep and quality of life in women who are receiving hormone therapy for treatment or prevention of breast cancer
PURPOSE This randomized clinical trial is studying giving venlafaxine together with zolpidem to see how well it works compared to venlafaxine alone in relieving hot flashes and associated sleep disorders in women who are receiving hormone therapy to treat or prevent breast cancer
PURPOSE This randomized clinical trial is studying giving venlafaxine together with zolpidem to see how well it works compared to venlafaxine alone in relieving hot flashes and associated sleep disorders in women who are receiving hormone therapy to treat or prevent breast cancer
Detailed Description:
OBJECTIVES
Compare the effect of venlafaxine or another serotonin-reuptake inhibitor with vs without zolpidem in terms of sleep continuity in women with breast cancer or at high risk for developing breast cancer who experience hot flushes and associated sleep disorders
Compare quality of life in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified by concurrent use of serotonin-reuptake inhibitors SRI
Stratum 1 no concurrent SRI Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral venlafaxine once daily and oral zolpidem once daily for 5 weeks
Arm II Patients receive oral venlafaxine once daily and oral placebo once daily for 5 weeks
Stratum 2 concurrently on SRI Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral zolpidem once daily for 5 weeks
Arm II Patients receive oral placebo once daily for 5 weeks NOTE After 5 weeks of study treatment patients in stratum 1 may taper or continue venlafaxine over 2 weeks for a total duration of venlafaxine use of 7 weeks patients in arm I of both strata may taper or continue zolpidem over 1 week for a total duration of zolpidem use of 6 weeks continuation or tapering of drugs in both arms occurs in an open-label fashion off study
In both strata treatment continues in the absence of unacceptable toxicity
In both strata hot flushes sleep continuity sleep quality and quality of life are assessed at baseline and at weeks 1 3 and 6
PROJECTED ACCRUAL A total of 119 patients will be accrued for this study within 20 months
Compare the effect of venlafaxine or another serotonin-reuptake inhibitor with vs without zolpidem in terms of sleep continuity in women with breast cancer or at high risk for developing breast cancer who experience hot flushes and associated sleep disorders
Compare quality of life in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified by concurrent use of serotonin-reuptake inhibitors SRI
Stratum 1 no concurrent SRI Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral venlafaxine once daily and oral zolpidem once daily for 5 weeks
Arm II Patients receive oral venlafaxine once daily and oral placebo once daily for 5 weeks
Stratum 2 concurrently on SRI Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral zolpidem once daily for 5 weeks
Arm II Patients receive oral placebo once daily for 5 weeks NOTE After 5 weeks of study treatment patients in stratum 1 may taper or continue venlafaxine over 2 weeks for a total duration of venlafaxine use of 7 weeks patients in arm I of both strata may taper or continue zolpidem over 1 week for a total duration of zolpidem use of 6 weeks continuation or tapering of drugs in both arms occurs in an open-label fashion off study
In both strata treatment continues in the absence of unacceptable toxicity
In both strata hot flushes sleep continuity sleep quality and quality of life are assessed at baseline and at weeks 1 3 and 6
PROJECTED ACCRUAL A total of 119 patients will be accrued for this study within 20 months
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 |
|---|---|---|---|
| DFCI-02311 | None | None | None |
| MGH-DFCI-02311 | None | None | None |