Acupuncture Treatment for Hot Flashes Study

NCT ID: NCT00421902

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

Acupuncture of the patients

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Patients will be have acupuncture (with electro stimulation)

Interventions

Acupuncture

Patients will be have acupuncture (with electro stimulation)

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

New York Presbyterian Brooklyn Methodist Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hani Ashamalla, MD

Chairman of Radiation Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hani Ashamalla, MD, FCCP

Role: PRINCIPAL_INVESTIGATOR

NY Methodist Hospital

Locations

NYP- Brooklyn Methodist Hospital

Brooklyn, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20605360 (View on PubMed)

Other Identifiers

NYM # 325

Identifier Type: -

Identifier Source: org_study_id