Acupuncture for Women's Health Conditions - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 25, 2004

Last Updated Date

January 23, 2008

Start Date ^†

January 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00090389 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Acupuncture for Women's Health Conditions

Official Title ^†

New England School of Acupuncture (NESA) Acupuncture Research Collaborative

Brief Summary

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

Detailed Description

This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy. 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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Ovarian Neoplasms
Endometriosis
Pelvic Pain
Uterine Neoplasms

Intervention ^†

Procedure: Chinese Acupuncture

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

May 2007

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility 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:

Currently closed to recruitment

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00090389

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Peter Wayne, PhD

New England School of Acupuncture

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.