Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

This study has been completed.

First Received: September 13, 2005 Last Updated: March 27, 2008 History of Changes

Sponsor:	University of Pittsburgh
Collaborators:	National Institutes of Health (NIH) National Cancer Institute (NCI)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177840

Purpose

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

Condition	Intervention	Phase
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Acupuncture Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Cancer-related fatigue [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

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
1: Experimental True acupuncture using true needles	Procedure: acupuncture
2: Sham Comparator sham acupuncture using sham needles	Procedure: acupuncture

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177840

Locations

United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
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

More Information

No publications provided

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

cancer-related fatigue
acupuncture
breast cancer

Additional relevant MeSH terms:

Signs and Symptoms
Neoplasms
Neoplasms by Site
Fatigue

Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010