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Acupuncture for Women's Health Conditions
This study has been completed.
Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
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
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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 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 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) |
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) |
| 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
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
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 ( U.S. NIH Grant/Contract ) |
| Study First Received: | August 25, 2004 |
| Last Updated: | January 23, 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 |
ClinicalTrials.gov processed this record on July 19, 2017