Acupuncture |
|
|
Clinical Trial: Acupuncture for Women's Health Conditions
This study is not yet open for patient recruitment.
|
Purpose
The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Ovarian Neoplasms Endometriosis Pelvic Pain Uterine Neoplasms | Procedure: Chinese Acupuncture | Phase I |
MedlinePlus related topics: Endometriosis; Ovarian Cancer; Pain; Uterine Cancer; Uterine Fibroids
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: New England School of Acupuncture (NESA) Acupuncture Research Collaborative
Expected Total Enrollment: 50
This trial comprises three studies. In the first two studies, women will be randomly assigned to receive either real or sham acupuncture therapy for 3 years. 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 above, Genders Eligible for Study: Female
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:
- 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
Location Information
Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States
Ursual Matulonis, MD, Principal Investigator
Weidong Lu, MPH, MAc, Principal Investigator
Peter Wayne, PhD, Principal Investigator, New England School of Acupuncture
More Information
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: August 25, 2004
ClinicalTrials.gov Identifier: NCT00090389
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Not Signed In -


