Ignite Creation Date:
2024-05-05 @ 11:05 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01255631
Status:
TERMINATED
Last Update Posted:
2015-10-16
First Post:
2010-12-01
Brief Title:
Pulsed Electromagnetic Fields PEMF and Post-Axillary Surgery Morbidity
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Use of Pulsed Electromagnetic Fields in Reducing Arm and Shoulder Complaints in Breast Cancer Patients After Lymph Node Dissection
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dissectionALND while having the axillary nodes assessed with a low false negative rate Approximately 30 of women who undergo ALND experience shoulderarm 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 bed1 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 ALNDSLND 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
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 bed1 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 ALNDSLND 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None