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

This study has been completed.
Sponsor:
Information provided by:
Legacy Health System
ClinicalTrials.gov Identifier:
NCT00419822
First received: January 8, 2007
Last updated: June 30, 2011
Last verified: May 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • Determine the difference in pain and range of motion [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
  • Determine the difference in function [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
  • Determine the difference in quality of life [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2006
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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)
  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: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Nathalie Johnson, MD, Legacy Health System
ClinicalTrials.gov Identifier: NCT00419822     History of Changes
Other Study ID Numbers: BCA-TCM-001
Study First Received: January 8, 2007
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014