Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN), Neuropathic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Reduction in Neuropathic Pain Intensity [Time frame: Baseline; 30 days after intervention; 60 days after intervention]
Secondary outcome measures (4)
- Reduction in Sensory Symptoms [Time frame: Baseline; 30 days after intervention; 60 days after intervention]
- Improvement in Segmental Strength [Time frame: Baseline; 30 days after intervention; 60 days after intervention]
- Adherence to Therapeutic Exercise [Time frame: Baseline; 30 days after intervention; 60 days after intervention]
- Rate of Discontinuation [Time frame: Up to 60 days (through study completion, up to 2 months)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- A.O.U.P. P. Giaccone, Palermo, Italia 90127 — Palermo
Identifiers
NCT: NCT07352514 · MFR032025