An observational study in Chemotherapy-induced Peripheral Neuropathy (CIPN) and Neuropathic Pain, sponsored by University of Palermo. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by University of Palermo · Observational
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.
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:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
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.
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.
Time frame: Baseline; 30 days after intervention; 60 days after intervention
Reduction in Sensory Symptoms
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!
Time frame: Baseline; 30 days after intervention; 60 days after intervention
Improvement in Segmental Strength
Recovery of segmental strength as assessed by the Medical Research Council (MRC) Scale.
Time frame: Baseline; 30 days after intervention; 60 days after intervention
Adherence to Therapeutic Exercise
Evaluation of adherence to therapeutic exercise, measured by step count with pedometer, duration of exercise, and perceived exertion (RPE Scale).
Time frame: Baseline; 30 days after intervention; 60 days after intervention
Rate of Discontinuation
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!
Time frame: Up to 60 days (through study completion, up to 2 months)
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