Status:
RECRUITING
Innovative Treatment of Chemotherapy-Induced Painful Peripheral Neuropathy in Adolescents and Young Adults With Cancer: A Two Arm Pilot Study
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of Scrambler therapy (ST) for chemotherapy-induced painful peripheral neuropathy (CIPN), and the impact of ST on physical functioning and quality of life (QoL) in a...
Detailed Description
Baseline Visit: If you agree to take part in this study, you will have a Baseline Visit (a visit done before you begin receiving ST). At this visit: You will have a physical exam. You will complete ...
Eligibility Criteria
Inclusion
- \- Both genders aged 15-39 years
- \- Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy.
- \- Patients have had cancer and are not being actively treated,
- \- 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
- \- Inability to walk or stand without assistance (need for ambulatory-assist devices)
- \- Bone and/or central nervous system metastases that affect gait, walking and balance
- \- History of other known or unknown causes of acute or chronic neuropathic and/or no neuropathic pain conditions.
- \- 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.
- \- History of epilepsy.
- \- Skin damage at the site of electrode placement; and i) prior ST treatment; j) Patients on pain medications for other than CIPN.
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05357469
Start Date
July 14 2022
End Date
July 31 2026
Last Update
November 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030