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OpenTrials
Completed

NCT Number: NCT00421902

Acupuncture Treatment for Hot Flashes Study

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NYP- Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

Patients will be have acupuncture (with electro stimulation)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

New York Presbyterian Brooklyn Methodist Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Jan 15, 2007
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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