The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.

Condition	Treatment or Intervention	Phase
Ovarian Neoplasms Endometriosis Pelvic Pain Uterine Neoplasms	Procedure: Chinese Acupuncture	Phase I

This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy for 3 years. Study 1 will include women with various forms of cancer. White blood cell counts will be used to assess the effects of acupuncture on participants' immune responses. Study 2 will include women with unspecified pelvic pain and endometriosis; a self-report pain scale will be used to assess the effects of acupuncture on participants' symptoms. Study 3 will evaluate the validity and reliability of diagnoses made by Chinese medicine practitioners. In this study, a group of Chinese medicine practitioners will diagnose the same group of patients; consistency of the diagnoses will be evaluated.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria for Study 1:

• Newly diagnosed ovarian cancer; primary peritoneal cancer; papillary serous cancer of the endometrium; or mixed mesodermal tumor of the uterus, ovary, or fallopian tube
• Currently undergoing chemotherapy
• Meet certain laboratory test requirements

Inclusion Criteria for Study 2:

• Diagnosed with endometriosis or unspecified pelvic pain

Exclusion Criteria for Studies 1 and 2:

• Use of white blood cell boosters
• Prior radiotherapy with the exception of whole-breast irradiation for breast cancer
• Prior myelotoxic chemotherapy
• History of symptomatic cardiac or psychiatric disorder
• Use of a pacemaker
• Use of herbs or herbal supplements
• Prior use of acupuncture
• Enrollment in other research studies

Peter Wayne, PhD      617-926-1788  Ext. 127    pwayne@nesa.edu

Massachusetts
      Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

Study chairs or principal investigators

Peter Wayne, PhD,  Principal Investigator,  New England School of Acupuncture   

Study ID Numbers:  U19 AT002022
Record last reviewed:  August 2004
Record first received:  August 25, 2004
ClinicalTrials.gov Identifier:  NCT00090389
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-05