Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Chemotherapy-induced Peripheral Neuropathy (CIPN), Neuropathic Pain. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Reduction in Neuropathic Pain Intensity [Срок оценки: Baseline; 30 days after intervention; 60 days after intervention]
Вторичные конечные точки (4)
- Reduction in Sensory Symptoms [Срок оценки: Baseline; 30 days after intervention; 60 days after intervention]
- Improvement in Segmental Strength [Срок оценки: Baseline; 30 days after intervention; 60 days after intervention]
- Adherence to Therapeutic Exercise [Срок оценки: Baseline; 30 days after intervention; 60 days after intervention]
- Rate of Discontinuation [Срок оценки: Up to 60 days (through study completion, up to 2 months)]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Италия · 1 центр
- A.O.U.P. P. Giaccone, Palermo, Italia 90127 — Palermo
Идентификаторы
NCT: NCT07352514 · MFR032025