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

L

Legacy Health System

Status

Completed

Conditions

Breast Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00419822
BCA-TCM-001

Details and patient eligibility

About

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).

Enrollment

30 estimated patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

30 participants in 3 patient groups, including a placebo group

Acupuncture
Active Comparator group
Treatment:
Procedure: Acupuncture
Sham Acupuncture
Sham Comparator group
Treatment:
Procedure: Sham Acupuncture
Standard of Care
Placebo Comparator group
Treatment:
Other: Patient to receive standard care without Acupuncture or Sham Acupuncture.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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