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Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00177840
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 28, 2008
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by:
University of Pittsburgh

Brief Summary:
This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in breast cancer patients undergoing radiation therapy.

Condition or disease Intervention/treatment Phase
Fatigue Procedure: acupuncture Phase 1

Detailed Description:
Each participant will have a baseline visit before her radiation therapy begins to complete questionnaires. Participants will receive either true acupuncture or sham acupuncture twice per week for the six weeks of radiation therapy. She will have a short questionnaire at three weeks into her radiation, and she will complete questionnaires again at the end of her radiation and four weeks later.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients
Study Start Date : September 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
True acupuncture using true needles
Procedure: acupuncture
Sham Comparator: 2
sham acupuncture using sham needles
Procedure: acupuncture



Primary Outcome Measures :
  1. Cancer-related fatigue [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Cancer-related fatigue distress [ Time Frame: 10 weeks ]
  2. Quality of life [ Time Frame: 10 weeks ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Localized breast cancer
  • Average to above average fatigue
  • Planning radiation therapy

Exclusion Criteria:

  • History of acupuncture treatment
  • Allergy to stainless steel
  • Pacemaker
  • Anticoagulant therapy
  • Known bleeding disorder
  • Metastatic breast cancer
  • Seizure disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177840


Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Judith Balk, MD MPH University of Pittsburgh

Responsible Party: Judith Balk, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177840     History of Changes
Other Study ID Numbers: 0506139
R21CA098659-01A2 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

Keywords provided by University of Pittsburgh:
cancer-related fatigue
acupuncture
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms