RecruitingNot Applicable

Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial

Italy40 participantsStarted 2025-03-15

Plain-language summary

This study aims to find out if taking specific dietary supplements (PEA and Scutellaria) along with therapeutic exercise can help reduce nerve pain and damage caused by chemotherapy. Many cancer patients experience nerve-related side effects from chemotherapy, which can significantly impact their quality of life. The study will observe patients who use these supplements and exercises to see if they can effectively manage and improve their nerve health and reduce pain.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 years and older. * Patients who have undergone chemotherapy treatment within the previous 6 months. * Patients treated with PEA, Scutellaria, and standardized therapeutic exercise according to the EXCAP protocol from April 2025 to September 2025. * Patients with a washout period from opioid-based analgesic therapy of at least 10 days or who are not receiving opioid-based analgesic therapy. * Patients presenting with neuropathic pain (NRS ≥ 5). * Patients able to provide written informed consent. Exclusion Criteria: * Patients younger than 18 years. * Patients with hypersensitivity to PEA or any of the excipients listed in the Summary of Product Characteristics (SPC). * Patients with diabetic pathology. * Patients with severe hepatic impairment. * Patients with severe disabilities that compromise the execution of therapeutic exercise.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in Neuropathic Pain Intensity

Timeframe: Baseline; 30 days after intervention; 60 days after intervention

Trial details

NCT IDNCT07352514

SponsorUniversity of Palermo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-20

Contact for this trial

Giulia Letizia Mauro

+39 0916554160 +39 09165541 giulia.letiziamauro@unipa.it

View on ClinicalTrials.gov More Chemotherapy-induced Peripheral Neuropathy (CIPN) trials