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NCT Number: NCT07352514

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

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN) Agnosia Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Palermo, Italia, 90127, Italy

Location status: Recruiting

Location contact

Letizia Mauro Professor

CONTACT

[email protected]

00390916554160

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Reduction in Neuropathic Pain Intensity

    Time frame: Baseline; 30 days after intervention; 60 days after intervention

    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.

Secondary outcomes

  1. Reduction in Sensory Symptoms

    Time frame: Baseline; 30 days after intervention; 60 days after intervention

    Reduction in sensory symptoms such as dysesthesia and paresthesia, and improvement in thermal and proprioceptive sensitivity.These secondary outcome measures help evaluate the broader effects of the intervention, in addition to the primary focus on neuropathic pain reduction. If you need further assistance or additional details, feel free to let me know!

  2. Improvement in Segmental Strength

    Time frame: Baseline; 30 days after intervention; 60 days after intervention

    Recovery of segmental strength as assessed by the Medical Research Council (MRC) Scale.

  3. Adherence to Therapeutic Exercise

    Time frame: Baseline; 30 days after intervention; 60 days after intervention

    Evaluation of adherence to therapeutic exercise, measured by step count with pedometer, duration of exercise, and perceived exertion (RPE Scale).

  4. Rate of Discontinuation

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

    Assessment of the rate of discontinuation of the treatment regimen.These secondary outcome measures help evaluate the broader effects of the intervention, in addition to the primary focus on neuropathic pain reduction. If you need further assistance or additional details, feel free to let me know!

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Letizia Mauro

CONTACT

[email protected]

+39 0916554160 +39 09165541

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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