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

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Supportive care
NCT ID
NCT03293940
Protocol IDs
RAD4068-17 (primary)
NCI-2017-01824
IRB00094527
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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.

Eligibility

  1. Subjects are status post (s/p) breast surgical intervention, to include mastectomy, partial mastectomy, lumpectomy, or reconstruction
  2. 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)
  3. Positive response to local anesthetic peripheral nerve block performed under imaging guidance, defined as a >= 50% change in Visual Analog Scale (VAS) pain intensity
  4. Ability and Willingness to provide informed consent

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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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