Acupuncture for Women's Health Conditions

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00090389
First received: August 25, 2004
Last updated: January 23, 2008
Last verified: January 2008
  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:


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

No publications provided

ClinicalTrials.gov Identifier: NCT00090389     History of Changes
Other Study ID Numbers: U19 AT002022
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 Alternative Medicine (NCCAM):
Acupuncture
Medicine, Chinese Traditional

Additional relevant MeSH terms:
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Endometriosis
Pelvic Pain
Ovarian Neoplasms
Uterine Neoplasms
Pain
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 22, 2014