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NCT00711529 · ClinicalTrials.gov registry record · Phase 3
Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.
A Phase 3 study, sponsored by Women and Infants Hospital of Rhode Island.
- Completed
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
NCT00711529 is a Phase 3 study that has completed, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 27 participants.
The verdict
NCT00711529, a Phase 3 study, has completed, sponsored by Women and Infants Hospital of Rhode Island.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
Study Summary
Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or chemotherapy are at risk for experiencing premature menopause because of their treatment. The resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's quality of life. Treatment for menopausal symptoms with the gold standard of hormone replacement therapy is not done routinely as it is unclear whether it can increase risk of tumor recurrence. In addition, many medical oncologists feel it is contraindicated in this population, especially among women whose breast cancers have estrogen receptors. This has lead to an increased interest in options other than estrogen replacement in the treatment of hot flashes, though most investigations of alternative medications have shown a suboptimal response. Recent studies have suggested that non-drug treatments using alternative or complementary therapies may be effective. Specifically, hypnosis has been promoted as a means to control hot flashes, though it has not been tested in a randomized fashion. In accordance with the National Cancer Institute's recent initiatives to expand the goals of clinical trials to include symptom management studies, our purpose is to evaluate the role of complementary and alternative therapies for improvement of symptoms in women with breast cancer. Specifically, we plan to evaluate the use of hypnotherapy for the treatment of therapy-induced hot flashes in breast cancer survivors. We intend to recruit 60 women into a pilot feasibility trial comparing hypnotherapy to the drug gabapentin (Neurontin®) for the treatment of therapy-induced hot flashes in eligible women who are receiving care at the Breast Health Center. We have chosen gabapentin based on recent studies showing it may be an effective non-estrogen treatment for this indication. We will identify patients who are experiencing at least one daily hot flash as a result of the treatment they received for their breast
Interventions
- BEHAVIORAL Hypnotherapy
- DRUG gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00711529
The ClinicalTrials.gov registry entry for NCT00711529 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hypnotherapy is the first listed.
NCT00711529 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00711529 about?
NCT00711529 is a clinical study titled "Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.". Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or chemotherapy are at risk for experiencing premature menopause because of their treatment. The resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's quality of life. Tre...
What is the current status of trial NCT00711529?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2008-07. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00711529?
The interventions under investigation include: Hypnotherapy (BEHAVIORAL), gabapentin (DRUG).
Who is sponsoring clinical trial NCT00711529?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
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