Innovative treatment for painful nerve damage in young cancer patients

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

This study is testing a new therapy called Scrambler to see if it can help young cancer patients with painful nerve damage caused by chemotherapy feel better and improve their daily life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05357469 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Scrambler therapy for treating chemotherapy-induced painful peripheral neuropathy in adolescents and young adults with cancer. Participants will undergo a baseline assessment, including physical exams and questionnaires about their symptoms and quality of life. They will then be randomly assigned to receive immediate Scrambler therapy or to a waitlist group, allowing researchers to compare outcomes between the two groups. The study aims to assess the impact of this therapy on pain relief and overall physical functioning.

Who should consider this trial

Good fit: Ideal candidates are adolescents and young adults aged 15-39 who have moderate symptoms of chemotherapy-induced peripheral neuropathy and are no longer undergoing active cancer treatment.

Not a fit: Patients who are unable to walk or stand without assistance or have other underlying causes of neuropathic pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain and improve quality of life for young cancer patients suffering from neuropathy.

How similar studies have performed: While the use of Scrambler therapy is a novel approach in this specific population, similar therapies have shown promise in treating neuropathic pain in other contexts.

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.

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Salahadin Abdi, MD — M.D. Anderson Cancer Center
• Study coordinator: Salahadin Abdi, MD

Conditions: Peripheral Neuropathy