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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00419822
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:
Legacy Health System

Brief Summary:
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).

Condition or disease Intervention/treatment
Breast Cancer Procedure: Acupuncture Procedure: Sham Acupuncture Other: Patient to receive standard care without Acupuncture or Sham Acupuncture.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2006
Primary Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Acupuncture Procedure: Acupuncture
6 Acupuncture visits
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



Primary Outcome Measures :
  1. Determine the difference in pain and range of motion [ Time Frame: 3 months after surgery ]
  2. Determine the difference in function [ Time Frame: 3 months after surgery ]
  3. Determine the difference in quality of life [ Time Frame: 3 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419822


Locations
United States, Oregon
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Legacy Health System
Investigators
Principal Investigator: Nathalie Johnson, MD Legacy Health System

Additional Information:
Responsible Party: Nathalie Johnson, MD, Legacy Health System
ClinicalTrials.gov Identifier: NCT00419822     History of Changes
Other Study ID Numbers: BCA-TCM-001
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: May 2010

Keywords provided by Legacy Health System:
Acupuncture
Range of Motion
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases