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Acupuncture for Women's Health Conditions

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 1

Conditions

Ovarian Neoplasms
Uterine Neoplasms
Pelvic Pain
Endometriosis

Treatments

Procedure: Chinese Acupuncture

Study type

Interventional

Funder types

NIH

Identifiers

NCT00090389
U19AT002022

Details and patient eligibility

About

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

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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