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

Active:	No
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT03293940
Trial Phases:	Phase II	Protocol IDs:	RAD4068-17 (primary) NCI-2017-01824 IRB00094527
Eligibility:	18 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03293940

Summary

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.

Objectives

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.

Treatment Sites in Georgia

Emory Johns Creek Hospital
6325 Hospital Parkway
Johns Creek, GA 30097
www.emoryjohnscreek.com

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

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