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Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00177840
First Posted: September 15, 2005
Last Update Posted: March 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by:
University of Pittsburgh
September 13, 2005
September 15, 2005
March 28, 2008
September 2005
July 2007   (Final data collection date for primary outcome measure)
Cancer-related fatigue [ Time Frame: 10 weeks ]
Cancer-related fatigue
Complete list of historical versions of study NCT00177840 on ClinicalTrials.gov Archive Site
  • Cancer-related fatigue distress [ Time Frame: 10 weeks ]
  • Quality of life [ Time Frame: 10 weeks ]
  • Cancer-related fatigue distress
  • Quality of life
Not Provided
Not Provided
 
Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients
Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients
This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in breast cancer patients undergoing radiation therapy.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Fatigue
Procedure: acupuncture
  • Experimental: 1
    True acupuncture using true needles
    Intervention: Procedure: acupuncture
  • Sham Comparator: 2
    sham acupuncture using sham needles
    Intervention: Procedure: acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
September 2007
July 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00177840
0506139
R21CA098659-01A2 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Judith Balk, University of Pittsburgh
University of Pittsburgh
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: Judith Balk, MD MPH University of Pittsburgh
University of Pittsburgh
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP