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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00209001 |
The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.
Condition | Intervention |
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Breast Cancer |
Procedure: Acupuncture Procedure: Sham acupuncture therapy Procedure: Observation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | July 2010 |
Arms | Assigned Interventions |
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2: Sham Comparator
sham acupuncture therapy
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Procedure: Sham acupuncture therapy
Sham procedure will be insertion of 5 needles for 20 minutes provided twice during first week, then once per week thereafter.
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1: Active Comparator
acupuncture
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Procedure: Acupuncture
Acupuncture using enhanced Ming Men technique for 20 minutes, twice during 1st week, then once during week 2, 3,and 4.
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3: No Intervention
observation
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Procedure: Observation
Observation without acupuncture.
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The purpose of this study is to determine if acupuncture is effective in relieving hot flashes in women treated with hormonal therapy for breast cancer.
Hormonal therapy is one of the most common treatments for breast cancer in women. Unfortunately, many women on hormonal therapy suffer from hot flashes (the sudden sensation of heat throughout the face, neck and chest, with or without shivering and sweating). Many medicines have been used to treat hot flashes, but no single medication has been found to work reliably.
Acupuncture has been shown to be effective for many conditions in Western medicine specifically for dry mouth in people who have received radiation to their head and neck, as well as for hot flashes in women during menopause (the "change of life"). In this study, we are investigating whether acupuncture is effective for women suffering hot flashes that result from their treatment of breast cancer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Emory University Winship Cancer Institute | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Peter Johnstone, MD | Emory University Winship Cancer Institute |
Responsible Party: | Winship Cancer Institute ( Peter Johnstone, MD ) |
Study ID Numbers: | 0533-2003 |
Study First Received: | September 13, 2005 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00209001 |
Health Authority: | United States: Institutional Review Board |
Breast Cancer |
Skin Diseases Hot Flashes Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |