Acupuncture for Women's Health Conditions

This study has been completed.

Sponsor:

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

ClinicalTrials.gov Identifier:

NCT00090389

First received: August 25, 2004

Last updated: January 23, 2008

Last verified: January 2008

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	New England School of Acupuncture (NESA) Acupuncture Research Collaborative

Resource links provided by NLM:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Acupuncture Uterine Cancer Women's Health

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):


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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Integrative Health (NCCIH)

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00090389 History of Changes
Other Study ID Numbers:	U19AT002022
Study First Received:	August 25, 2004
Last Updated:	January 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):


Acupuncture Medicine, Chinese Traditional

Additional relevant MeSH terms:


Genital Diseases, Female Genital Neoplasms, Female Neoplasms Endometriosis Pelvic Pain Ovarian Neoplasms Uterine Neoplasms Pain Neurologic Manifestations	Signs and Symptoms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Uterine Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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