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

University of Palermo

Status: Enrolling

Conditions: Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy (CIPN)

Study type: Observational

Funder types: Other

Identifiers

NCT07352514

MFR032025

Details and patient eligibility

About

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.

Full description

Chemotherapy-induced peripheral neuropathy (CIPN) is a significant and common complication affecting 30-60% of cancer patients undergoing chemotherapy. CIPN results in damage to sensory, motor, autonomic, or cranial nerves, leading to debilitating neuropathic pain. This condition poses a substantial burden on healthcare resources and significantly impacts patients' quality of life. Effective management of neuropathic pain through pharmacological and rehabilitative treatments is crucial in both the acute and chronic phases.

The study aims to evaluate the efficacy of a combined treatment regimen involving nutraceuticals, specifically palmitoylethanolamide (PEA) and Scutellaria, along with therapeutic exercise, in patients suffering from post-chemotherapy peripheral neuropathy. The rationale behind this combination therapy is based on the anti-inflammatory and neuroprotective properties of PEA and Scutellaria, coupled with the beneficial effects of physical exercise on neuropathic pain and overall nerve health.

Study Design: This study is a clinical observational, prospective cohort study. Patients with CIPN due to chemotherapy will be enrolled and monitored over a period of time to observe the effects of the combined treatment on their neuropathic symptoms. The study is post-market and will not involve any investigational drugs. Patients will be divided into three treatment groups:

• Patients receiving PEA + Scutellaria + therapeutic exercise.
• Patients receiving only therapeutic exercise. . Patients receiving only PEA + Scutellaria.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 3 patient groups

PEA + Scutellaria + Therapeutic Exercise

Description:

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

Description:

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

Description:

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.