About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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!
Improvement in Segmental Strength
Recovery of segmental strength as assessed by the Medical Research Council (MRC) Scale.
Adherence to Therapeutic Exercise
Evaluation of adherence to therapeutic exercise, measured by step count with pedometer, duration of exercise, and perceived exertion (RPE Scale).
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!
Sponsors and contacts
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