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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients

Resource links provided by NLM:


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
Experimental: 1
True acupuncture using true needles
Procedure: acupuncture
Sham Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Judith Balk, MD MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: Judith Balk, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177840     History of Changes
Other Study ID Numbers: 0506139, R21 CA098659-01A2
Study First Received: September 13, 2005
Last Updated: March 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
cancer-related fatigue
acupuncture
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014