Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00084669
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE June 10, 2004
First Posted Date  ICMJE June 11, 2004
Last Update Posted Date April 28, 2010
Study Start Date  ICMJE May 2004
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Sleep improvement by biologic data and actigraphy data at the end of study treatment
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00084669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Hot Flashes
  • Sleep Disorders
Intervention  ICMJE
  • Drug: venlafaxine
  • Drug: zolpidem tartrate
  • Procedure: management of therapy complications
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
119
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00084669
Other Study ID Numbers  ICMJE CDR0000365502
MGH-DFCI-02311
DFCI-02311
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadine Joffe, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hadine Joffe, MD, MSC Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP