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Acupuncture Treatment for Hot Flashes Study

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ClinicalTrials.gov Identifier: NCT00421902
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
New York Methodist Hospital

January 12, 2007
January 15, 2007
April 6, 2018
January 2006
June 2010   (Final data collection date for primary outcome measure)
Relief from the hot flashes as determined by the hot flashes scoring system. [ Time Frame: 6 months ]
A Questionnaire was given to the patients to determine the relief of hot flashes
Relief from the hot flashes as determined by the hot flashes scoring system.
Complete list of historical versions of study NCT00421902 on ClinicalTrials.gov Archive Site
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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
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. Acupuncture was done according to specific guidelines and mapping.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Intervention Model Description:
Acupuncture to pevent hot flushes
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Procedure: Acupuncture
Patients will be have acupuncture (with electro stimulation)
Experimental: Acupuncture
Acupuncture of the patients
Intervention: Procedure: Acupuncture
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. doi: 10.1016/j.ijrobp.2010.01.025. Epub 2010 Jun 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
June 2012
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00421902
NYM # 325
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New York Methodist Hospital
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
April 2018

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