Acupuncture for Women's Health Conditions

NCT ID: NCT00090389

Last Updated: 2008-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ovarian Neoplasms Endometriosis Pelvic Pain Uterine Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Chinese Acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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


Currently closed to recruitment

* Diagnosed with endometriosis or unspecified pelvic pain

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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Peter Wayne, PhD

Role: PRINCIPAL_INVESTIGATOR

New England School of Acupuncture

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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U19AT002022

Identifier Type: NIH

Identifier Source: org_study_id

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