Chemotherapy-induced Peripheral Neuropathy (CIPN)NCT07352514
Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial
An observational study of Chemotherapy-induced Peripheral Neuropathy (CIPN) and Neuropathic Pain, run by University of Palermo at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN), Neuropathic Pain
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2025to Apr 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
A.O.U.P. P. Giaccone, Palermo, Italia 90127
Palermo, Italia, 90127
Letizia Mauro Professor, 00390916554160, giulia.letiziamauro@unipa.it
About this study
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.
Read the detailed 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.
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy, Neuropathic Pain, Nutraceuticals, Palmitoylethanolamide, Scutellaria, Therapeutic Exercise, Cancer Patients, Pain Management, Neuropathy Treatment, Clinical Trial, Observational Case-Control Study
- Medical subject headings
- Neuralgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PEA + Scutellaria + Therapeutic Exercise | 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 | 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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 30 days after intervention; 60 days after intervention
Secondary outcomes (4)
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!
Measured: 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.
Measured: 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).
Measured: 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!
Measured: Up to 60 days (through study completion, up to 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Mar 2025
- Primary completion20 Feb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352514
- Sponsor's protocol ID
- MFR032025
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No