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Use of Pulsed Electromagnetic Fields in Reducing Arm and Shoulder Complaints in Breast Cancer Patients After Lymph Node Dissection


Phase 4
18 Years
N/A
Not Enrolling
Female
Shoulder Symptoms After Lymph Node Dissection

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Trial Information

Use of Pulsed Electromagnetic Fields in Reducing Arm and Shoulder Complaints in Breast Cancer Patients After Lymph Node Dissection


In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two
hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already
designed a lightweight, disposable device that can be placed around the patient's arm and
taped in place. The patient would keep the device in place for two weeks, when they return
for a followup visit and receive a fresh device to wear for an additional two weeks.


Inclusion Criteria:



- Inclusion criteria include patients undergoing axillary lymph node dissection or
sentinel lymph node dissection for breast cancer. Patients undergoing lumpectomy with
the axillary surgery will be included.

Exclusion Criteria:

- Patients undergoing mastectomy with the axillary surgery will be excluded.

- Patients with prior axillary radiation or prior arm impairment will be excluded.

- Patients with pacemakers will be excluded.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pain Level on Visual Analog Scale

Outcome Description:

Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours postop), then daily for a total of two weeks postop.

Outcome Time Frame:

2 weeks

Safety Issue:

No

Principal Investigator

Christine Rohde, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University

Authority:

United States: Institutional Review Board

Study ID:

AAAE3803

NCT ID:

NCT01255631

Start Date:

November 2010

Completion Date:

July 2012

Related Keywords:

  • Shoulder Symptoms After Lymph Node Dissection

Name

Location
Columbia University Medical Center New York, New York  10032