Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

Fatigue Clinical Trial

Official title:

Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177840
• Other study ID #: 0506139
• Secondary ID: R21CA098659-01A2
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: March 27, 2008
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: March 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Procedure:
• acupuncture

Locations

Country	Name	City	State
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-related fatigue		10 weeks	No
Secondary	Cancer-related fatigue distress		10 weeks	No
Secondary	Quality of life		10 weeks	No