Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究者
Prof.ssa Giulia Letizia Mauro
Professor
University of Palermo