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

NCT ID: NCT00419822

Last Updated: 2011-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acupuncture

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

6 Acupuncture visits

Sham Acupuncture

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type PROCEDURE

6 Acupuncture visits with sham procedure

Standard of Care

Group Type PLACEBO_COMPARATOR

Patient to receive standard care without Acupuncture or Sham Acupuncture.

Intervention Type OTHER

Standard care

Interventions

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Acupuncture

6 Acupuncture visits

Intervention Type PROCEDURE

Sham Acupuncture

6 Acupuncture visits with sham procedure

Intervention Type PROCEDURE

Patient to receive standard care without Acupuncture or Sham Acupuncture.

Standard care

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Legacy Health System

OTHER

Sponsor Role lead

Responsible Party

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Legacy Health System

Principal Investigators

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Nathalie Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Legacy Health System

Locations

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Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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BCA-TCM-001

Identifier Type: -

Identifier Source: org_study_id

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