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| Descriptive Information Fields | |||||
| Brief Title † | Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer | ||||
| Official Title † | Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Define efficacy of acupuncture to points of the enhanced Ming Men technique for relief of hot flashes after hormonal therapy for breast cancer. [ Time Frame: weekly evaluation up to 9 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Breast Cancer | ||||
| Intervention † | Procedure: Acupuncture Procedure: Sham acupuncture therapy Procedure: Observation |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 30 | ||||
| Start Date † | July 2003 | ||||
| Completion Date | July 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00209001 | ||||
| Organization ID | 0533-2003 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Emory University | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Emory University | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | March 5, 2008 | ||||