Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study

Launched by M.D. ANDERSON CANCER CENTER · Apr 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Scrambler Therapy (ST) to help relieve painful nerve damage known as chemotherapy-induced painful peripheral neuropathy (CIPN) in young people aged 15 to 39 who have had cancer. The goal is to see if ST can reduce pain and improve the quality of life and physical functioning of these patients. The trial is currently looking for participants who experience moderate pain from CIPN, have completed their cancer treatment, and can communicate in English.

If you or someone you know qualifies and decides to participate, you’ll be randomly assigned to either receive Scrambler Therapy or to wait for treatment while being monitored. Throughout the trial, participants will complete questionnaires to track their pain levels and overall well-being. This study aims to find out if Scrambler Therapy is a safe and effective option for managing CIPN in young cancer survivors, potentially leading to better pain management strategies for this group.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. - Both genders aged 15-39 years
• • 2. - Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy.
• • 3. - Patients have had cancer and are not being actively treated,
• • 4. - Patients who speaks English and able to complete questionnaires by themselves or with help from parents and/or nurses. Written informed consent will be obtained from adults (aged 18-39 years) or from parents/guardians of adolescents (aged 15-17 years) and assent will be obtained from adolescents (aged 15-17 years) under an Institutional Review Board (IRB)-approved protocol.
• Exclusion Criteria:
• • 1. - Inability to walk or stand without assistance (need for ambulatory-assist devices)
• • 2. - Bone and/or central nervous system metastases that affect gait, walking and balance
• • 3. - History of other known or unknown causes of acute or chronic neuropathic and/or no neuropathic pain conditions.
• • 4. - Implanted intrathecal drug-delivery system or a spinal cord and/or peripheral nerve stimulator;
• • a) a metal implant such as a cardiac pacemaker, automatic defibrillator, aneurysm clips, vena cava clips, or skull plate.
• • 5. - History of epilepsy.
• • 6. - Skin damage at the site of electrode placement; and i) prior ST treatment; j) Patients on pain medications for other than CIPN.