Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
BMJ Open. 2023 Aug 21;13(8):e071858. doi: 10.1136/bmjopen-2023-071858.
BACKGROUND: Malnutrition is a frequent problem in oncology and is associated with reduced response to cancer treatments, increased drug-related toxicity, higher rates of clinical complications, reduced quality of life (QoL) and worse prognosis. Guidelines on clinical nutrition in oncology emphasise the usefulness of early assessment of nutritional status for a prompt identification of malnutrition and the implementation of effective interventions, but no real-world clinical data are available on the adequate management of nutritional support in patients with cancer in Italy. METHODS AND ANALYSIS: This is an observational, longitudinal, multicentre registry of patients with a new diagnosis of cancer or metastatic disease, candidates for active treatment. They will be identified in at least 15 Italian oncological centres, members of the Alliance Against Cancer Working Group 'Survivorship Care and Nutritional Support'. At least 1500 patients with cancer are expected to be enrolled each year. Detailed clinical and nutritional data will be collected by oncologists and clinical nutritionists during the visits foreseen in the clinical practice, through an ad hoc developed digital platform (e-Nutracare). The effects of malnutrition and nutritional support-at diagnosis and during follow-up-on overall survival and progression-free survival, as well as on patients' symptoms and QoL, will be investigated. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Fondazione IRCCS Policlinico San Matteo, Pavia, Italy and from the Ethics Committees of all other participating centres. An informed consent will be obtained from each patient enrolled in the study. Study findings will be disseminated through peer-reviewed journals, conferences and patients with cancer or professional associations. The registry will allow a better monitoring of the nutritional status of patients with cancer, promoting adequate and sustainable nutritional support, with the ultimate goal of improving the care and prognosis of these patients.
背景：营养不良是肿瘤学中的一个常见问题，与癌症治疗反应降低、药物相关毒性增加、临床并发症发生率升高、生活质量下降以及预后恶化有关。肿瘤临床营养指南强调了早期评估营养状况的重要性，以便及时发现营养不良并实施有效的干预措施，但目前在意大利，尚无关于癌症患者营养支持管理的真实临床数据。
方法和分析：这是一项观察性、纵向、多中心登记研究，纳入了新诊断为癌症或转移性疾病、有积极治疗适应证的患者。这些患者将在至少 15 个意大利肿瘤中心中被识别出来，这些中心都是抗癌联盟工作组“生存护理和营养支持”的成员。预计每年将有至少 1500 名癌症患者入组。通过专门开发的数字平台（e-Nutracare），肿瘤学家和临床营养师将在临床实践中预计进行的访视期间收集详细的临床和营养数据。将研究营养不良和营养支持（在诊断时和随访期间）对总生存期和无进展生存期以及患者症状和生活质量的影响。
伦理和传播：该研究方案已获得意大利帕维亚圣马泰奥基金会 IRCCS 综合医院伦理委员会以及所有其他参与中心伦理委员会的批准。将从每个入组研究的患者处获得知情同意书。研究结果将通过同行评议期刊、会议以及癌症患者或专业协会进行传播。该登记处将能够更好地监测癌症患者的营养状况，促进适当和可持续的营养支持，最终目标是改善这些患者的护理和预后。
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