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.
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.
Study Type
OBSERVATIONAL
Enrollment
40
A.O.U.P. P. Giaccone, Palermo, Italia 90127
Palermo, Italia, Italy
RECRUITINGReduction 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
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
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
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
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)
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