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Sponsors and Collaborators: |
University of Pittsburgh National Institutes of Health (NIH) National Cancer Institute (NCI) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177840 |
This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in breast cancer patients undergoing radiation therapy.
Condition | Intervention | Phase |
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Fatigue |
Procedure: acupuncture |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients |
Estimated Enrollment: | 54 |
Study Start Date: | September 2005 |
Study Completion Date: | September 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
True acupuncture using true needles
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Procedure: acupuncture |
2: Sham Comparator
sham acupuncture using sham needles
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Procedure: acupuncture |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Magee-Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
Magee-Womens Hospital | |
pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Judith Balk, MD MPH | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Judith Balk ) |
Study ID Numbers: | 0506139, R21 CA098659-01A2 |
Study First Received: | September 13, 2005 |
Last Updated: | March 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00177840 |
Health Authority: | United States: Institutional Review Board |
cancer-related fatigue acupuncture breast cancer |
Signs and Symptoms Fatigue Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |