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Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177840
First received: September 13, 2005
Last updated: March 27, 2008
Last verified: March 2008

September 13, 2005
March 27, 2008
September 2005
July 2007   (final data collection date for primary outcome measure)
Cancer-related fatigue [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Cancer-related fatigue
Complete list of historical versions of study NCT00177840 on ClinicalTrials.gov Archive Site
  • Cancer-related fatigue distress [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177840
0506139, R21 CA098659-01A2
No
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