Acupuncture Treatment for Hot Flashes Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by New York Methodist Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
New York Methodist Hospital
Information provided by:
New York Methodist Hospital
ClinicalTrials.gov Identifier:
NCT00421902
First received: January 12, 2007
Last updated: NA
Last verified: November 2006
History: No changes posted
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 12, 2007 | ||||||||
| Last Updated Date | January 12, 2007 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Relief from the hot flashes as determined by the hot flashes scoring system. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Acupuncture Treatment for Hot Flashes Study | ||||||||
| Official Title ICMJE | Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study | ||||||||
| Brief Summary | Patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered Acupuncture as an investigational intervention. The treatment is performed twice a week for four weeks, then once a week for the following six weeks |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Prostate Cancer | ||||||||
| Intervention ICMJE | Procedure: Acupuncture | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Ashamalla H, Jiang ML, Guirguis A, Peluso F, Ashamalla M. Acupuncture for the alleviation of hot flashes in men treated with androgen ablation therapy. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1358-63. Epub 2010 Jun 3. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | July 2010 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00421902 | ||||||||
| Other Study ID Numbers ICMJE | NYM # 325 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | New York Methodist Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | New York Methodist Hospital | ||||||||
| Verification Date | November 2006 | ||||||||
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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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