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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Palermo

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 3 trial groups
Group A: PEA + Scutellaria + Therapeutic Exercise
Group B: Therapeutic Exercise Only
Group C: PEA + Scutellaria Only

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

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
4

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)

Other outcomes

Sponsors and contacts

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