Back to resultsAcupuncture for Women's Health Conditions
Primary Purpose
Ovarian Neoplasms, Endometriosis, Pelvic Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Chinese Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Acupuncture, Medicine, Chinese Traditional
Eligibility 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
Sites / Locations
- Dana Farber Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00090389
First Posted
August 25, 2004
Last Updated
January 23, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00090389
Brief Title
Acupuncture for Women's Health Conditions
Official Title
New England School of Acupuncture (NESA) Acupuncture Research Collaborative
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of acupuncture in treating women's health conditions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Endometriosis, Pelvic Pain, Uterine Neoplasms
Keywords
Acupuncture, Medicine, Chinese Traditional
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Chinese Acupuncture
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Wayne, PhD
Organizational Affiliation
New England School of Acupuncture
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Women's Health Conditions
We'll reach out to this number within 24 hrs