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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
  Purpose

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


Condition Intervention Phase
Prostate Cancer
 Procedure: Acupuncture
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York Methodist Hospital:

Primary Outcome Measures:
  • Relief from the hot flashes as determined by the hot flashes scoring system.

Estimated Enrollment: 50
Study Start Date: January 2006
Estimated Study Completion Date: July 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421902

Contacts
Contact: Hani Ashamalla, MD, FCCP 718 780 3677 hashamalla@aol.com
Contact: Adel Guirguis, MD, MS 718 780 3677 adg9003@nyo.org

Locations
United States, New York
NY Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Adel Guirguis, MD, MS     718-780-3677     adg9003@nyp.org    
Principal Investigator: Hani Ashamalla, MD, FCCP            
Sub-Investigator: Francis Florio, MD            
Sub-Investigator: Bahaa Mokhtar, MD            
Sponsors and Collaborators
New York Methodist Hospital
Investigators
Principal Investigator: Hani Ashamalla, MD, FCCP NY Methodist Hospital
Study Director: Adel Guirguis, MD, MS NY Methodist Hospital
  More Information

No publications provided by New York Methodist Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00421902     History of Changes
Other Study ID Numbers: NYM # 325
Study First Received: January 12, 2007
Last Updated: January 12, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by New York Methodist Hospital:
Hot flashes, prostate cancer, acupuncture
Prostate cancer patients with hot flashes due to their hormonal treatment

Additional relevant MeSH terms:
Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013