Acupuncture for Women's Health Conditions

Endometriosis Clinical Trial

Official title:

New England School of Acupuncture (NESA) Acupuncture Research Collaborative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090389
• Other study ID #: U19AT002022
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2004
• Last updated: January 23, 2008
• Start date: January 2005
• Est. completion date: May 2007

Study information

• Verified date: January 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Neoplasms
• Ovarian Neoplasms
• Pelvic Pain
• Uterine Neoplasms

Intervention

Procedure:
• Chinese Acupuncture

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,