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Acupuncture for Women's Health Conditions

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ClinicalTrials.gov Identifier: NCT00090389
Recruitment Status : Completed
First Posted : August 26, 2004
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Endometriosis Pelvic Pain Uterine Neoplasms Procedure: Chinese Acupuncture Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: New England School of Acupuncture (NESA) Acupuncture Research Collaborative
Study Start Date : January 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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ClinicalTrials.gov Identifier: NCT00090389     History of Changes
Other Study ID Numbers: U19AT002022 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2004    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008

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