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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

March 27, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Cancer-related fatigue

Change History

Complete list of historical versions of study NCT00177840 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Cancer-related fatigue distress
Quality of life

Descriptive Information

Brief Title ^ICMJE

Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Fatigue

Intervention ^ICMJE

Procedure: acupuncture

Study Arms / Comparison Groups

Experimental: True acupuncture using true needles
Sham Comparator: sham acupuncture using sham needles

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00177840

Responsible Party

Judith Balk, University of Pittsburgh

Study ID Numbers ^ICMJE

0506139, R21 CA098659-01A2

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Judith Balk, MD MPH

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

March 2008

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