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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relief from the hot flashes as determined by the hot flashes scoring system.

Principal Investigator

Hani Ashamalla, MD, FCCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

NY Methodist Hospital

Authority:

United States: Institutional Review Board

Study ID:

NYM # 325

NCT ID:

NCT00421902

Start Date:

January 2006

Completion Date:

July 2010

Related Keywords:

  • Prostate Cancer
  • Hot flashes, prostate cancer, acupuncture
  • Prostate cancer patients with hot flashes due to their hormonal treatment
  • Prostatic Neoplasms
  • Hot Flashes

Name

Location

NY Methodist HospitalBrooklyn, New York  11215