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Acupuncture Treatment for Hot Flashes Study

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
New York Presbyterian Brooklyn Methodist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hot flashes, prostate cancer, acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • NYP- Brooklyn Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

Acupuncture of the patients

Outcomes

Primary Outcome Measures

Relief from the hot flashes as determined by the hot flashes scoring system.
A Questionnaire was given to the patients to determine the relief of hot flashes

Secondary Outcome Measures

Full Information

First Posted
January 12, 2007
Last Updated
September 16, 2020
Sponsor
New York Presbyterian Brooklyn Methodist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00421902
Brief Title
Acupuncture Treatment for Hot Flashes Study
Official Title
Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Presbyterian Brooklyn Methodist Hospital

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hot flashes, prostate cancer, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Acupuncture to pevent hot flushes
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture of the patients
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Patients will be have acupuncture (with electro stimulation)
Primary Outcome Measure Information:
Title
Relief from the hot flashes as determined by the hot flashes scoring system.
Description
A Questionnaire was given to the patients to determine the relief of hot flashes
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hani Ashamalla, MD, FCCP
Organizational Affiliation
NY Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYP- Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20605360
Citation
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.
Results Reference
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Acupuncture Treatment for Hot Flashes Study

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