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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
Sponsor:
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

January 12, 2007
January 12, 2007
January 2006
Not Provided
Relief from the hot flashes as determined by the hot flashes scoring system.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Acupuncture Treatment for Hot Flashes Study
Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Procedure: Acupuncture
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 2010
Not Provided

Inclusion Criteria:

  • Treatment for prostate cancer using hormonal ablation therapy
  • Average of three or more hot flashes a day
  • Performance Status (Karnofsky ≥ 60)
  • Patients must be ≥ 18 years of age
  • No other clinically significant disease
  • Signed study-specific consent form prior to study entry

Exclusion Criteria:

  • Initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study
  • Pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients’ condition have been stable for 4 weeks)
  • Skin infections
  • Patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.
Male
18 Years and older
No
Contact: Hani Ashamalla, MD, FCCP 718 780 3677 hashamalla@aol.com
Contact: Adel Guirguis, MD, MS 718 780 3677 adg9003@nyo.org
United States
 
NCT00421902
NYM # 325
Not Provided
Not Provided
New York Methodist Hospital
Not Provided
Principal Investigator: Hani Ashamalla, MD, FCCP NY Methodist Hospital
Study Director: Adel Guirguis, MD, MS NY Methodist Hospital
New York Methodist Hospital
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP