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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Acupuncture; Procedure: Sham Acupuncture; Other: Patient to receive standard care without Acupuncture or Sham Acupuncture.

• Registration Number: NCT00419822
• Lead Sponsor: Legacy Health System

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-09
• Status Verified: 2010-05
• Primary Completion: 2011-03
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	-
Sham Acupuncture	Sham Acupuncture	-
Standard of Care	Patient to receive standard care without Acupuncture or Sham Acupuncture.	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Legacy Good Samaritan Hospital and Medical Center; 🇺🇸 Portland, Oregon, United States