Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Ivivi Health Sciences, LLC
Information provided by (Responsible Party):
Christine Hsu Rohde, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01255631
First received: December 1, 2010
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

The most important prognostic indicator for the breast cancer patient is the axillary lymph node status. With the introduction of the sentinel lymph node biopsy, many women were spared the morbidity of a full axillary lymph node dissection(ALND) while having the axillary nodes assessed with a low false negative rate. Approximately 30% of women who undergo ALND experience shoulder/arm morbidity including numbness, pain, weakness and decreased range of motion. In addition, the sentinel lymph node dissection (SLND) held the promise that women with early stage breast cancer would be able to avoid the dreaded morbidity associated with axillary lymph node dissections including lymphedema, decreased range of motion and pain. Since the adoption of SLN, numerous papers have documented that SLN is superior to ALND. However, patients who undergo SLN still have a significant amount of pain with this procedure. There are few published studies which objectively assess the subjective and objective symptoms of SLND.

Pulsed electromagnetic fields (PEMF) have been shown to be effective in the treatment of fractures and spinal fusion, relief of pain in acute sprains and whiplash injuries, improvement of skin blood flow, healing of venous stasis ulcers, and reduction of postmastectomy lymphedema. Indeed, radiofrequency PEMF devices are FDA approved for pain and edema relief. PEMF devices are economical and disposable, and can be incorporated unobtrusively in standard post-op dressings. We have recently reported, in a double-blind, placebo-controlled study on breast reduction, that post-op PEMF therapy produced a significant decrease in pain and pain medication use, along with a concomitant decrease in IL1-beta in the wound bed.1 The current pilot study will be designed to determine if PEMF treatment, given in addition to standard of care, can reduce post-operative discomfort and morbidity after lumpectomy and SLND, or lumpectomy and ALND. Lumpectomy and ALND/SLND patients enrolled in the double-blind, placebo-controlled study will undergo standard surgery, but will be randomized to one of two groups: the treatment group with a PEMF coil placed around the arm and the control group with a coil that delivers no PMF. We expect postoperative pain to be reduced in the PEMF-treated patients as well as improved arm mobility and strength. The use of PEMF might reduce the need for narcotic pain medications and their side effects of sedation, nausea, and vomiting. It may also reduce costs related to arm morbidity.


Condition Intervention Phase
Shoulder Symptoms After Lymph Node Dissection
Device: PEMF Device
Device: Sham PEMF Device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Pulsed Electromagnetic Fields in Reducing Arm and Shoulder Complaints in Breast Cancer Patients After Lymph Node Dissection

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Pain Level on Visual Analog Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Subjective symptoms would be recorded before surgery, and after surgery, at two weeks, six weeks, and six months. Patients will be given a survey to rate their pain, muscle strength, range of motion, and arm edema based on criteria published in Helms et al. 2009 in EJSO.

  • Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Objective symptoms and findings would be recorded before surgery, and after surgery, at two weeks, six weeks, and six months. Patients will undergo a short physical exam to assess pain, muscle strength, range of motion, arm edema, and sensation based on criteria published in Helms et al. 2009 in EJSO.

  • Lymphedema [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    In addition to taking arm circumference to measure arm edema, we will use the Lymphedema Index (L-Dex) by Impedimed Inc. The L-Dex is noninvasive and FDA approved. It provides a more direct and accurate measurement of lymphedema than arm circumference. The L-Dex detects differences in the amount of extracellular fluid between the left and right arm by sending a painless electrical signal through the body via electrodes placed on both wrists and one ankle. Greater extracellular fluid allows the signal to travel more easily (less impedance).

  • Drain output [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    If the patient undergoes an ALND, a #10 Jackson-Pratt (JP) drain may be placed in the axilla as part of standard postoperative procedures. The amount of exudate that fills the drain is normally recorded, and we will record exudate volume until the patient is discharged.

  • Narcotic Pain Medications [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The amount of pain medication taken by the patient will be recorded then converted to Percocet equivalents for 2 weeks post-op.


Enrollment: 6
Study Start Date: November 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham PEMF device Device: Sham PEMF Device
Inactive PEMF device, delivers no PMF
Active Comparator: PEMF Device Device: PEMF Device
The PEMF device we will use in this study is FDA approved for "adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue" (510(k) number: K903675). There are no side effects to use of a PEMF device. 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.
Other Name: Ivivi Sofpulse Torino

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255631

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Ivivi Health Sciences, LLC
Investigators
Principal Investigator: Christine Rohde, MD Columbia University
  More Information

Publications:
Responsible Party: Christine Hsu Rohde, MD, Assistant Professor of Clinical Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT01255631     History of Changes
Other Study ID Numbers: AAAE3803
Study First Received: December 1, 2010
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014