Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients - Tabular View

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Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

This study has been completed.
Information provided by University of Pittsburgh

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

Official Title ^†

Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients

Brief Summary

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

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 Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Fatigue

Intervention ^†

Procedure: acupuncture

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

September 2005

Completion Date

September 2007

Eligibility 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

Gender

Female

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00177840

Organization ID

0506139

Secondary IDs ^††

R21 CA098659-01A2

Study Sponsor ^†

University of Pittsburgh

Collaborators ^††

National Institutes of Health (NIH)
National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

Judith Balk, MD MPH

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

March 2008

First Received Date ^†

September 13, 2005

Last Updated Date

March 27, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.