Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Patients

June 30, 2011 updated by: Legacy Health System

A Randomized, Intent to Treat, Controlled Study of the Efficacy of Verum Acupuncture Compared to Sham Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Subjects That Have Undergone Axillary Surgery

This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to control pain and improve range of motion (arm movement). Another goal is to find out if women have an improvement in their quality of life. This study is being done in collaboration with the Oregon College of Oriental Medicine (OCOM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female subjects
  • Expected survival at least 6 months or greater
  • Has had surgery with axillary dissection
  • Greater than 6 nodes removed during surgery
  • Greater than 21 years of age

Exclusion Criteria:

  • Previous mastectomy
  • Double mastectomy at the time of current axillary surgery
  • Any diagnoses of autoimmune disease
  • Pregnant or lactating women
  • Unable to provide written informed consent
  • Suspected or diagnosed fibromyalgia
  • Previous shoulder injuries for the specific arm that will undergo axillary dissection
  • Known or suspected drug or alcohol abuse as determined by the investigator
  • Decreased range of motion (ROM) as evidenced on standard preoperative exam
  • Previous acupuncture (lifetime)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Acupuncture
Procedure: Sham Acupuncture
6 Acupuncture visits with sham procedure
Placebo Comparator: Standard of Care
Other: Patient to receive standard care without Acupuncture or Sham Acupuncture.
Standard care
Active Comparator: Acupuncture
Procedure: Acupuncture
6 Acupuncture visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the difference in pain and range of motion
Time Frame: 3 months after surgery
3 months after surgery
Determine the difference in function
Time Frame: 3 months after surgery
3 months after surgery
Determine the difference in quality of life
Time Frame: 3 months after surgery
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Legacy Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

July 4, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCA-TCM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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