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

NCT07352514 | Recruiting

• 1 other identifier: MFR032025
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

Chemotherapy-Induced Peripheral Neuropathy; Neuropathic Pain; Nutraceuticals; Palmitoylethanolamide; Scutellaria; Therapeutic Exercise; Cancer Patients; Pain Management; Neuropathy Treatment; Clinical Trial; Observational Case-Control Study

Outcome Measures

Primary Outcomes (1)

• Reduction in Neuropathic Pain Intensity

  The primary outcome measure is the reduction in the intensity of neuropathic pain as assessed by the Numerical Rating Scale (NRS) from baseline (day 0) to the first follow-up visit (day 30) and the second follow-up visit (day 60).This primary outcome measure evaluates the efficacy of the combined treatment regimen (PEA, Scutellaria, and therapeutic exercise) in reducing neuropathic pain in patients with chemotherapy-induced peripheral neuropathy.

  Baseline; 30 days after intervention; 60 days after intervention

Secondary Outcomes (4)

• Reduction in Sensory Symptoms

  Baseline; 30 days after intervention; 60 days after intervention

• Improvement in Segmental Strength

  Baseline; 30 days after intervention; 60 days after intervention

• Adherence to Therapeutic Exercise

  Baseline; 30 days after intervention; 60 days after intervention

• Rate of Discontinuation

  Up to 60 days (through study completion, up to 2 months)

Study Arms (3)

PEA + Scutellaria + Therapeutic Exercise

This group consists of patients who will receive a combination of palmitoylethanolamide (PEA) and Scutellaria along with a standardized therapeutic exercise regimen. The goal is to evaluate the synergistic effects of the nutraceuticals and exercise in reducing neuropathic pain and improving overall nerve health.

Therapeutic Exercise Only

Patients in this group will participate in a standardized therapeutic exercise program without any additional nutraceutical intervention. This cohort will help determine the efficacy of therapeutic exercise alone in managing symptoms of chemotherapy-induced peripheral neuropathy (CIPN).

PEA + Scutellaria Only

This group includes patients who will be treated with a combination of PEA and Scutellaria without participating in any structured exercise regimen. The aim is to assess the impact of the nutraceuticals alone on reducing neuropathic pain and improving nerve function.

Eligibility Criteria

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

Study Population

The study participants will be selected from adult patients (aged 18 years and older) attending oncology and neurology clinics at major hospitals in Palermo, Sicilia, Italia. These patients have undergone chemotherapy treatment within the last 6 months and are experiencing chemotherapy-induced peripheral neuropathy (CIPN). The source of the participants includes both the Oncology Department and the Pain Management Unit, ensuring a diverse and representative sample of the target population.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

A.O.U.P. P. Giaccone, Palermo, Italia 90127

Palermo, Italia, 90127, Italy

RECRUITING

MeSH Terms

Conditions

Neuralgia; Agnosia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Central Study Contacts

Giulia Letizia Mauro

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: January 20, 2026
• Study Start: March 15, 2025
• Primary Completion: February 20, 2026
• Study Completion: April 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-03

Locations

IT (1)