RecruitingNot ApplicableNCT05357469

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

38 participants

Start Date

Jul 14, 2022

Study Type

INTERVENTIONAL

Conditions

Peripheral Neuropathy

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 adolescents and young adults (AYA) cancer patients. In this proposed study, we will conduct a two-arm prospective, randomized wait-list controlled clinical trial to investigate the effectiveness of ST on pain and CIPN in AYAs with cancer.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

\- 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 Criteria7

\- 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.