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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

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 Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Acupuncture to pevent hot flushes
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study
Actual Study Start Date : January 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Acupuncture of the patients
Procedure: Acupuncture
Patients will be have acupuncture (with electro stimulation)




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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


Locations
United States, New York
NY Methodist Hospital
Brooklyn, New York, United States, 11215
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York Methodist Hospital
ClinicalTrials.gov Identifier: NCT00421902     History of Changes
Other Study ID Numbers: NYM # 325
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by New York Methodist Hospital:
Hot flashes, prostate cancer, acupuncture

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