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

NCT05357469 | Recruiting DMC FDA Device

• 3 other identifiers: 2021-0657NCI-2022-038321R21CA256136-01A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)

  Five functional scales (physical, role, cognitive, emotional, and social); nine symptom scales (fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties); and a global health status/QoL. Based on 30 questions in total, the scores range from 0 to 100.

  through study completion, an average of 1 year

Study Arms (2)

Immediate St (Scrambler Therapy)

EXPERIMENTAL

Participant will start ST (Scrambler Therapy) treatment right away.

Device: Immediate St (Scrambler Therapy)

Waitlist ST (Scrambler Therapy)

EXPERIMENTAL

Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.

Device: Waitlist ST (Scrambler Therapy)

Interventions

Immediate St (Scrambler Therapy) DEVICE

Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments).

Immediate St (Scrambler Therapy)

Waitlist ST (Scrambler Therapy) DEVICE

Participant will receive Scrambler Therapy one (1) time a day, Monday through Friday, for up to 2 weeks (a total of 10 ST treatments).

Waitlist ST (Scrambler Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Salahadin Abdi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salahadin Abdi, MD

CONTACT

(713) 792-0883; sabdi@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: July 14, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)