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

Not Applicable

Completed

• Conditions: Breast Cancer; Hot Flashes; Sleep Disorders

• Registration Number: NCT00084669
• Lead Sponsor: Massachusetts General Hospital

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.

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-06-10
• Study First Submitted QC: 2004-06-10
• Study First Posted: 2004-06-11
• Primary Completion: 2007-10
• Study Completion: 2010-03
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-27
• Last Update Posted: 2010-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 119

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep improvement by biologic data and actigraphy data at the end of study treatment

Secondary Outcome Measures

Name	Time	Method
Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States