Image Guided Cryosurgery in Managing Post Mastectomy Pain Syndrome in Patients That Have Undergone Mastectomy, Partial Mastectomy, Lumpectomy, or Breast Reconstruction
18 Years and older, Male and Female
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.
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.
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).
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.
- 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
Treatment Sites in Georgia
**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