Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Patients
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
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 8, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedJuly 4, 2011
May 1, 2010
4.5 years
January 8, 2007
June 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Determine the difference in pain and range of motion
3 months after surgery
Determine the difference in function
3 months after surgery
Determine the difference in quality of life
3 months after surgery
Study Arms (3)
Acupuncture
ACTIVE COMPARATORSham Acupuncture
SHAM COMPARATORStandard of Care
PLACEBO COMPARATORInterventions
Standard care
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalie Johnson, MD
Legacy Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 8, 2007
First Posted
January 9, 2007
Study Start
September 1, 2006
Primary Completion
March 1, 2011
Last Updated
July 4, 2011
Record last verified: 2010-05