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Acupuncture Treatment for Hot Flashes Study

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ClinicalTrials.gov Identifier: NCT00421902
Recruitment Status : Unknown
Verified November 2006 by New York Methodist Hospital.
Recruitment status was:  Recruiting
First Posted : January 15, 2007
Last Update Posted : January 15, 2007
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Acupuncture Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study
Study Start Date : January 2006
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: November 2006

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