Acupuncture Treatment for Hot Flashes Study

NCT00421902 | Completed

• 1 other identifier: NYM # 325
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Hot flashes, prostate cancer, acupuncture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Acupuncture

EXPERIMENTAL

Acupuncture of the patients

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Patients will be have acupuncture (with electro stimulation)

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

NYP- Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Related Publications (1)

• 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.

  PMID: 20605360 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Hot Flashes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Hani Ashamalla, MD, FCCP

  NY Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Radiation Oncology Department

Model Details: Acupuncture to pevent hot flushes

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 15, 2007
• Study Start: January 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2012
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

US (1)