NCT00419822
Completed
Not Applicable
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
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Legacy Health System
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Determine the difference in pain and range of motion
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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).
Investigators
Eligibility 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)
Outcomes
Primary Outcomes
Determine the difference in pain and range of motion
Time Frame: 3 months after surgery
Determine the difference in function
Time Frame: 3 months after surgery
Determine the difference in quality of life
Time Frame: 3 months after surgery
Study Sites (1)
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