Acupuncture Treatment for Hot Flashes Study

Prostate Cancer Clinical Trial

Official title:

Acupuncture Treatment for Hot Flashes in Men With Prostate Cancer, A Phase I/II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421902
• Other study ID #: NYM # 325
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Est. completion date: June 2012

Study information

• Verified date: September 2020
• Source: New York Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Acupuncture
Patients will be have acupuncture (with electro stimulation)

Locations

Country	Name	City	State
United States	NYP- Brooklyn Methodist Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Methodist Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months