Clinical Trial: Understanding Experimentally Induced Hot Flushes

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Understanding Experimentally Induced Hot Flushes

Brief Summary:

The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. Hot flushes (or "hot flashes") are a feeling of being overheated, and often are followed by heavy sweating, skin becoming red and hot, and discomfort. Sometimes hot flushes are followed by chills. Some women experience a rapid heart rate. Hot flushes that happen at night are called night sweats, and they may interfere with sleep.

The investigators will cause hot flushes by giving study participants a hormone medication called leuprolide (Lupron). Hormones are chemicals that are naturally produced in the body. Leuprolide is a manufactured (artificial) hormone that will make the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide.

The investigators will also evaluate changes in sleep, mood, and feelings of well-being over the course of the study. The investigators will use questionnaires to measure these changes.

Detailed Summary:

Hot flushes are common in peri/postmenopausal women and women receiving breast cancer therapies. Every year in the United States, 1.3 million women are expected to reach menopause.(1, 2) Hot flushes occur in >85% of menopausal women, typically persisting for several years.(3) In addition, over 200,000 women are diagnosed with breast cancer in the US each year.(4) Hot flushes are the most common side effect of anti-estrogen therapies used to treat estrogen-receptor positive (ER+) breast cancer. Widely used anti-estrogen therapies are used continuously for many years, and include tamoxifen, aromatase inhibitors (AI), and gonadotropin-releasing hormone (GnRH) agonists.(5) Hot flushes persist with ongoing use of these cancer treatments.(6) The number of women with hot flushes has been increasing because many women have declined estrogen therapy since the results of the Women's Health Initiative were published and because anti-estrogen therapies are now used more widely over longer periods of time in women with breast cancer.(7) Hot flushes impair quality-of-life by producing discomfort, disrupting sleep, diminishing mood, and reducing overall well-being in menopausal women and breast cancer patients.(5, 8) They are the primary reason for discontinuation of anti-estrogen therapies.(9) Recent advances have identified non-hormonal therapies for hot flushes (e.g., serotonergic agents and gabapentin),(8, 10-16) but such agents are effective in only 60% of women with hot flushes.(8) Better therapies are needed. Current studies are limited by reliance on populations with hot flushes that vary in frequency and intensity, biases in perceptions that influence self-reporting of hot flushes,(17) and a 30% placebo-response rate.(8, 18) Utilizing an experimental model to induce hot flushes will advance the discovery of novel hot flush therapies through the use of a robust and reproducible system in which to test potential therapies. An
Sponsor: Hadine Joffe, MD

Current Primary Outcome: To examine the impact of hot flushes on sleep, mood, and well-being. [ Time Frame: Baseline and post-treatment (4 weeks after GnRH agonist) ]

Original Primary Outcome:

Current Secondary Outcome: To describe the hormonal dynamics after administration of a gonadotropin-releasing hormone agonist that are associated with the development of hot flushes. [ Time Frame: Baseline and post-treatment (4 weeks after GnRH agonist) ]

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: April 2, 2007
Date Started: November 2005
Date Completion: October 2012
Last Updated: April 25, 2012
Last Verified: April 2012