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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | May 12, 2009 | ||||
| Start Date ICMJE | July 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00209001 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Acupuncture for Hot Flashes in Women Treated With Hormonal Therapy for Breast Cancer | ||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 7 | ||||
| Estimated Completion Date | July 2010 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00209001 | ||||
| Responsible Party | Peter Johnstone, MD, Winship Cancer Institute | ||||
| Study ID Numbers ICMJE | 0533-2003 | ||||
| Study Sponsor ICMJE | Emory University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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