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

NCT01255631 | Terminated Phase 4 Results DMC

• 1 other identifier: AAAE3803
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Symptoms After Lymph Node Dissection

Outcome Measures

Primary Outcomes (1)

• Pain Level on Visual Analog Scale

  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 post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain).

  2 weeks

Secondary Outcomes (5)

• Jackson Pratt (JP) Drain Output

  Post-Operative Day 1 & 2 (2 Days)

• Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF

  Pre- and Post-Operative Period

• Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF

  Pre- and Post-Operative Period

• Lymphedema

  Pre- and Post-Operative Period

• Narcotic Pain Medications

  Post-Operative Period

Study Arms (2)

Sham PEMF device

SHAM COMPARATOR

Device: Sham PEMF Device

PEMF Device

ACTIVE COMPARATOR

Device: PEMF Device

Interventions

PEMF Device 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.

Also known as: Ivivi Sofpulse Torino

PEMF Device

Sham PEMF Device DEVICE

Inactive PEMF device, delivers no PMF

Sham PEMF device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• Helms G, Kuhn T, Moser L, Remmel E, Kreienberg R. Shoulder-arm morbidity in patients with sentinel node biopsy and complete axillary dissection--data from a prospective randomised trial. Eur J Surg Oncol. 2009 Jul;35(7):696-701. doi: 10.1016/j.ejso.2008.06.013. Epub 2008 Oct 5.

  PMID: 18838245 BACKGROUND

• Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA. Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. Plast Reconstr Surg. 2010 Jun;125(6):1620-1629. doi: 10.1097/PRS.0b013e3181c9f6d3.

  PMID: 20527063 BACKGROUND

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Christine Rohde
• Organization: CUMC Plastic Surgery

chr2111@cumc.columbia.edu

212-342-3707

Study Officials

• Christine Rohde, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Surgery

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 7, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 16, 2015
• Results First Posted: October 16, 2015

Record last verified: 2015-09

Locations

US (1)