Shoulder Symptoms After Lymph Node Dissection Clinical Trial
Official title:
Use of Pulsed Electromagnetic Fields in Reducing Arm and Shoulder Complaints in Breast Cancer Patients After Lymph Node Dissection
| Verified date | September 2015 |
| Source | Columbia University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 22 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Columbia University Medical Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Columbia University |
United States,
Helms G, Kühn 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. — View Citation
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):1620-9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Jackson Pratt (JP) Drain Output | Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study. | Post-Operative Day 1 & 2 (2 Days) | No |
| Secondary | Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF | No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points. | Pre- and Post-Operative Period | No |
| Secondary | Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF | No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points. | Pre- and Post-Operative Period | No |
| Secondary | Lymphedema | No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed. | Pre- and Post-Operative Period | No |
| Secondary | Narcotic Pain Medications | No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed. | Post-Operative Period | No |