CompletedNot Applicable

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

United States119 participantsStarted 2004-05

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 oc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00084669

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-10

View on ClinicalTrials.gov More Breast Cancer trials