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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419822
• Other study ID #: BCA-TCM-001
• Status: Completed
• Phase: N/A
• First received: January 8, 2007
• Last updated: June 30, 2011
• Start date: September 2006

Study information

• Verified date: May 2010
• Source: Legacy Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Acupuncture
6 Acupuncture visits
• Sham Acupuncture
6 Acupuncture visits with sham procedure

Other:
• Patient to receive standard care without Acupuncture or Sham Acupuncture.
Standard care

Locations

Country	Name	City	State
United States	Legacy Good Samaritan Hospital and Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Legacy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the difference in pain and range of motion		3 months after surgery	No
Primary	Determine the difference in function		3 months after surgery	No
Primary	Determine the difference in quality of life		3 months after surgery	No

External Links

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