Expired Study
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Boston, Massachusetts 02115


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

U19 AT002022


NCT ID:

NCT00090389


Secondary ID:


Study Acronym:


Brief Title:

Acupuncture for Women's Health Conditions


Official Title:

New England School of Acupuncture (NESA) Acupuncture Research Collaborative


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Complementary and Alternative Medicine (NCCAM)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:


Overall Contact Information

Official Name:Peter Wayne, PhD
Principal Investigator
New England School of Acupuncture

Study Dates

Start Date:January 2005
Completion Date:May 2007
Completion Type:Actual
Primary Completion Date:May 2007
Primary Completion Type:Actual
Verification Date:January 2008
Last Changed Date:January 23, 2008
First Received Date:August 25, 2004

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Procedure
Name:Chinese Acupuncture

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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