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Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

Primary Purpose

Fatigue

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

acupuncture

About this trial

This is an interventional treatment trial for Fatigue focused on measuring cancer-related fatigue, acupuncture, breast cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Magee-Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm Description

True acupuncture using true needles

sham acupuncture using sham needles

Outcomes

Primary Outcome Measures

Cancer-related fatigue

Secondary Outcome Measures

Cancer-related fatigue distress

Quality of life

Full Information

NCT ID

NCT00177840

First Posted

September 13, 2005

Last Updated

March 27, 2008

Sponsor

University of Pittsburgh

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00177840

Brief Title

Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

Official Title

Acupuncture for Cancer-Related Fatigue in Breast Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Pittsburgh

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatigue

Keywords

cancer-related fatigue, acupuncture, breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

True acupuncture using true needles

Arm Title

Arm Type

Sham Comparator

Arm Description

sham acupuncture using sham needles

Intervention Type

Procedure

Intervention Name(s)

acupuncture

Primary Outcome Measure Information:

Title

Cancer-related fatigue

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Cancer-related fatigue distress

Time Frame

10 weeks

Title

Quality of life

Time Frame

10 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith Balk, MD MPH

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Magee-Womens Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

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