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
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Cancer-Related Problem/Condition
Intervention: venlafaxine (Drug); zolpidem tartrate (Drug); management of therapy complications (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Hadine Joffe, MD, MSC, Study Chair, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction
Study design: Supportive Care, Randomized, Double-Blind, Placebo Control
Primary outcome: Sleep improvement by biologic data and actigraphy data at the end of study treatment
Secondary outcome: Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Clinical Trials Office - Dana-Farber/Harvard Cancer Center, Phone: 617-582-8480
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Clinical Trials Office - Massachusetts General Hospital, Phone: 877-726-5130
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: May 2004
Last updated: October 18, 2008
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