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Status:

COMPLETED

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

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Breast Cancer

Hot Flashes

Eligibility:

FEMALE

18-65 years

Phase:

NA

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 re...

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 develop...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • At increased risk of developing breast cancer, meeting 1 of the following criteria:
  • Diagnosis of 1 of the following:
  • Ductal carcinoma in situ
  • Invasive breast cancer
  • Lobular carcinoma in situ
  • Atypical ductal or lobular hyperplasia
  • Lobular carcinoma
  • Candidate for breast cancer risk reduction for any of the following:
  • Predisposing mutation in a breast cancer susceptibility gene
  • Prior chest radiotherapy for Hodgkin's disease
  • Gail model score \> 1.67% over 5 years
  • Experiencing daytime and nocturnal hot flushes at least 14 times per week within the past 2 weeks
  • Experiencing sleep disturbance, characterized by the presence of all of the following for ≥ 1 month:
  • ≥ 3 awakenings per night occurring ≥ 3 nights per week
  • Insomnia impedes daytime function
  • Hot flushes are the primary cause of insomnia (determined at baseline visit)
  • Hormone receptor status:
  • Not specified
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 65
  • Sex
  • Female
  • Menopausal status
  • Not specified
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • At least 6 months
  • Hematopoietic
  • Not specified
  • Hepatic
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No clinically significant cardiac disease
  • No uncontrolled hypertension within the past 3 months, defined as the following:
  • Diastolic blood pressure \> 95 mm Hg on \> 1 occasion
  • Systolic blood pressure \> 160 mm Hg on \> 1 occasion
  • Pulmonary
  • No clinically significant respiratory disease
  • Psychiatric
  • Beck depression inventory score ≤ 15
  • No active panic or depressive disorder within the past month
  • No lifetime history of bipolar or psychotic disorder
  • No active substance-use disorders, including alcohol and benzodiazepines, within the past year
  • No suicidal or homicidal ideation
  • No hypomania or mania
  • Other
  • No prior adverse reaction to venlafaxine or zolpidem
  • None of the following sleep disorders within the past 6 months:
  • Sleep apnea
  • Narcolepsy
  • Periodic limb movement disturbance
  • No abuse or misuse of study medication
  • No daytime sedation that interferes with ability to function
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 1 month after study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • More than 3 months since prior chemotherapy
  • No concurrent chemotherapy
  • Endocrine therapy
  • More than 1 month since prior regular use (\> 25% of the time) of oral, transdermal, or injection preparations of androgens, estrogens, or progestins
  • Vaginal suppositories and creams allowed
  • No concurrent regular use of oral, transdermal, or injection preparations of androgens, estrogens, or progestins
  • Radiotherapy
  • See Disease Characteristics
  • More than 3 months since prior radiotherapy
  • No concurrent radiotherapy
  • Surgery
  • See Disease Characteristics
  • Other
  • More than 1 month since prior regular use (\> 25% of the time) of any of the following:
  • Hypnotic agents (e.g., benzodiazepines, zolpidem, zaleplon, trazodone, or diphenhydramine)
  • Clonidine
  • More than 1 month since prior antidepressants or other medications that are known to influence mood \> 25% of the time (no serotonin-reuptake inhibitors \[SRI\] stratum only)
  • Concurrent SRI required provided they were initiated ≥ 1 month ago at or above the minimum dose, including any of the following (concurrent SRI stratum only):
  • Fluoxetine
  • Paroxetine
  • Paroxetine CR
  • Sertraline
  • Citalopram
  • S-citalopram
  • Venlafaxine
  • Fluvoxamine
  • No concurrent warfarin
  • No concurrent hypnotic agents, clonidine, or antidepressants, or other medications known to influence sleep, or mood

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2010

    Estimated Enrollment :

    119 Patients enrolled

    Trial Details

    Trial ID

    NCT00084669

    Start Date

    May 1 2004

    End Date

    March 1 2010

    Last Update

    April 28 2010

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    2

    Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02115-6084