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
Condition: Breast Cancer; Hot Flashes; Sleep Disorders
MeSH terms: Breast Neoplasms; Sleep Wake Disorders; Parasomnias; Hot Flashes
Study type: Interventional

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.
    

Intervention name(s): venlafaxine; zolpidem tartrate; management of therapy complications
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Zolpidem; Venlafaxine Hydrochloride
Allocation: Randomized
Masking: Double
Primary purpose: Supportive Care
Keywords: hot flashes; sleep disorders; ductal breast carcinoma in situ; breast cancer in situ; lobular breast carcinoma in situ; lobular breast carcinoma; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer