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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084669 |
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.
Condition | Intervention |
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Breast Cancer Cancer-Related Problem/Condition |
Drug: venlafaxine Drug: zolpidem tartrate Procedure: management of therapy complications |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction |
Estimated Enrollment: | 119 |
Study Start Date: | May 2004 |
OBJECTIVES:
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.
Stratum 2 (concurrently on SRI): Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At increased risk of developing breast cancer, meeting 1 of the following criteria:
Diagnosis of 1 of the following:
Candidate for breast cancer risk reduction for any of the following:
Experiencing sleep disturbance, characterized by the presence of all of the following for ≥ 1 month:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No uncontrolled hypertension within the past 3 months, defined as the following:
Pulmonary
Psychiatric
Other
None of the following sleep disorders within the past 6 months:
PRIOR CONCURRENT THERAPY:
Biologic therapy
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
Radiotherapy
Surgery
Other
More than 1 month since prior regular use (> 25% of the time) of any of the following:
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):
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115-6084 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Study Chair: | Hadine Joffe, MD, MSC | Massachusetts General Hospital |
Study ID Numbers: | CDR0000365502, MGH-DFCI-02311, DFCI-02311 |
Study First Received: | June 10, 2004 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00084669 |
Health Authority: | United States: Federal Government |
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 |
Zolpidem Skin Diseases Hot Flashes Breast Neoplasms Sleep Disorders Serotonin Recurrence Carcinoma Signs and Symptoms |
Carcinoma, Lobular Mental Disorders Carcinoma in Situ Venlafaxine Flushing Neurologic Manifestations Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Breast Diseases |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Serotonin Uptake Inhibitors Pharmacologic Actions Neoplasms |
Neoplasms by Site Serotonin Agents GABA Agonists Therapeutic Uses Hypnotics and Sedatives GABA Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |