Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction
- 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
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Sleep improvement by biologic data and actigraphy data at the end of study treatment
Hadine Joffe, MD, MSC
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|