Acupuncture for Women's Health Conditions
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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 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 |
| 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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| 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 Ovarian Neoplasms Pelvic Pain Uterine Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Ovarian Diseases Adnexal Diseases Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Pain Signs and Symptoms Uterine Diseases |
ClinicalTrials.gov processed this record on May 23, 2013