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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


N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Determine the difference in pain and range of motion

Outcome Time Frame:

3 months after surgery

Safety Issue:

No

Principal Investigator

Nathalie Johnson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Legacy Health System

Authority:

United States: Institutional Review Board

Study ID:

BCA-TCM-001

NCT ID:

NCT00419822

Start Date:

September 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Acupuncture
  • Range of Motion
  • Quality of Life
  • Breast Neoplasms

Name

Location

Legacy Good Samaritan Hospital and Medical CenterPortland, Oregon  97210