Image Guided Cryosurgery in Managing Post Mastectomy Pain Syndrome in Patients That Have Undergone Mastectomy, Partial Mastectomy, Lumpectomy, or Breast Reconstruction

Status: Active

Description

This randomized pilot phase II trial studies how well image guided cryosurgery works in managing post mastectomy pain syndrome in patients that have undergone mastectomy, partial mastectomy, lumpectomy, or breast reconstruction. Image guided cryosurgery involves using a computed tomography (CT) scan to help guide a needle inserted through the skin into the targeted nerve, and uses a freezing effect that may work better in reducing the pain felt from the mastectomy, partial mastectomy, lumpectomy, or breast reconstruction.

Eligibility Criteria

Inclusion Criteria

  • Subjects are status post (s/p) breast surgical intervention, to include mastectomy, partial mastectomy, lumpectomy, or reconstruction
  • Subjects report persistent pain in the distribution of the intercostobrachial nerve (ICBN): The residual breast, surgical bed, ipsilateral medial arm, and/or axilla following tissue healing (> 3 months post-procedure)
  • Positive response to local anesthetic peripheral nerve block performed under imaging guidance, defined as a >= 50% change in Visual Analog Scale (VAS) pain intensity
  • Ability and Willingness to provide informed consent

Exclusion Criteria

  • Active Infection
  • Underlying cervical segmentation or other cervical spinal anomaly that results in differential nerve root pressures
  • Location of pain is outside the distribution of the ICBN, can be directly attributable to trauma to a nerve other than the ICBN, or is consistent with trauma during breast surgery to a nerve other than the ICNB (e.g. medial and lateral pectoral nerve; long thoracic nerve; thoracodorsal nerve; other intercostal nerves)
  • Immunosuppression
  • Uncorrectable coagulopathy
  • Currently pregnant, nursing or planning to become pregnant

Locations & Contacts

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: Active
Contact: John David Prologo
Phone: 404-778-2656
Email: john.david.prologo@emory.edu
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: John David Prologo
Phone: 404-712-7033
Email: john.david.prologo@emory.edu
Emory University Hospital Midtown
Status: Active
Contact: John David Prologo
Phone: 404-778-2656
Email: john.david.prologo@emory.edu
Johns Creek
Emory Johns Creek Hospital
Status: Active
Contact: John David Prologo
Phone: 404-778-2656
Email: john.david.prologo@emory.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To establish the validity of the cryoablation comparative peripheral nerve block approach in patients with post-mastectomy pain syndrome (PMPS) and to compare the response to cryoablation to that of a therapeutic peripheral nerve block on improvements in PMPS symptoms over a follow-up period of 6-months.

SECONDARY OBJECTIVES:

I. Evaluating differences in health-related quality of life variables over the course of 6 months in patients with PMPS that undergo cryoablation compared to those that receive a therapeutic peripheral nerve block injection (tPNB).

TERTIARY OBJECTIVES:

I. To support all efficacy conclusions, complementary analyses will be performed to determine if there are differences in the safety and tolerability profiles between cryoablation and tPNB.

II. To empower clinicians and researchers with a set of thresholds that can be used to determine which patients have responded to treatment.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients undergo CT and then undergo cryosurgery for the targeted nerve over 25-45 minutes.

GROUP 2: Patients undergo CT and then receive injection of bupivacaine hydrochloride and betamethasone into the targeted nerve.

After completion of study treatment, patients are followed up for 180 days.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Supportive care

Lead Organization

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
John David Prologo

Trial IDs

Primary ID RAD4068-17
Secondary IDs NCI-2017-01824, IRB00094527
Clinicaltrials.gov ID NCT03293940