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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

Primary Purpose

Breast Cancer, Hot Flashes, Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
venlafaxine
zolpidem tartrate
management of therapy complications
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Outcomes

Primary Outcome Measures

Sleep improvement by biologic data and actigraphy data at the end of study treatment

Secondary Outcome Measures

Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment

Full Information

First Posted
June 10, 2004
Last Updated
April 27, 2010
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00084669
Brief Title
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
Targeting Insomnia to Enhance Hot Flush Treatment in Women Receiving Therapy for Breast Cancer or Breast Cancer Risk-Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hot Flashes, Sleep Disorders
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
119 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
venlafaxine
Intervention Type
Drug
Intervention Name(s)
zolpidem tartrate
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Primary Outcome Measure Information:
Title
Sleep improvement by biologic data and actigraphy data at the end of study treatment
Secondary Outcome Measure Information:
Title
Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadine Joffe, MD, MSC
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6084
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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