Acupuncture for Women's Health Conditions

This study has been completed.

First Received: August 25, 2004 Last Updated: January 23, 2008 History of Changes

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00090389

Purpose

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

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

MedlinePlus related topics: Acupuncture Cancer Endometriosis Ovarian Cancer Pelvic Pain Uterine Cancer Women's Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	New England School of Acupuncture (NESA) Acupuncture Research Collaborative

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	50
Study Start Date:	January 2005
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090389

Locations

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

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Peter Wayne, PhD

New England School of Acupuncture

More Information

No publications provided

Study ID Numbers:	U19 AT002022
Study First Received:	August 25, 2004
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00090389 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Acupuncture
Medicine, Chinese Traditional

Study placed in the following topic categories:

Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Uterine Diseases
Endocrine System Diseases
Pain
Endometriosis
Urogenital Neoplasms

Ovarian Diseases
Genital Diseases, Female
Signs and Symptoms
Pelvic Pain
Ovarian Cancer
Uterine Neoplasms
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Uterine Diseases
Endocrine System Diseases
Pain
Endometriosis
Urogenital Neoplasms
Ovarian Diseases

Adnexal Diseases
Genital Diseases, Female
Signs and Symptoms
Neoplasms
Pelvic Pain
Neoplasms by Site
Uterine Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009