免疫营养对接受营养咨询的头颈癌患者提高放化疗耐受性的疗效：一项随机、开放标签、平行组、双中心试点研究的研究方案
The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study.
作者信息
Caccialanza Riccardo, Cereda Emanuele, Klersy Catherine, Nardi Mariateresa, Masi Sara, Crotti Silvia, Cappello Silvia, Caissutti Valentina, Brovia Carlotta, Lobascio Federica, Formisano Elena, Colombo Sara, Filippi Andrea Riccardo, Bonzano Elisabetta, Comoli Patrizia, Catenacci Laura, Alberti Andrea, Musella Valeria, Ferrari Alessandra, Imarisio Ilaria, Tancredi Richard, Monaco Teresa, Ghi Maria Grazia, Bossi Paolo, Pedrazzoli Paolo
机构信息
Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, Pavia, 27100, Italy.
Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
出版信息
Ther Adv Med Oncol. 2021 Sep 11;13:17588359211025872. doi: 10.1177/17588359211025872. eCollection 2021.
BACKGROUND
Nutritional support, including nutritional counseling and oral nutritional supplements (ONSs), has been recommended at the earliest opportunity in head and neck (H&N) cancer patients. The limited available evidence on the efficacy of immunonutrition during chemoradiotherapy (CT-RT) in H&N cancer patients is positive with regard to some secondary endpoints, but is still scanty, particularly with regard to toxicity and treatment tolerance. We hypothesize that early systematic provision of ONSs with a high-protein-high-calorie mixture containing immunonutrients (Impact) compared to standard high-calorie-high-protein nutritional blends, in addition to nutritional counseling, may be beneficial to patients with H&N cancer during CT-RT. Hence, we designed the present study to evaluate the efficacy, in terms of treatment tolerance, toxicity and response, body weight, body composition, protein-calorie intake, quality of life (QoL), fatigue, muscle strength and immunological profile of the early systematic provision of ONSs enriched in immunonutrients compared to isonitrogenous standard blends, in H&N cancer patients undergoing CT-RT.
METHODS
This is a pragmatic, bicentric, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial.
DISCUSSION
Many efforts are still to be taken to improve the efficacy of nutritional support in oncology. Immunonutrition represents a promising approach also in H&N cancer patients, but the evidence on its efficacy in improving clinical outcomes during CT-RT is still inconclusive. The present pilot study, which guarantees the early provision of nutritional assessment and support to all the enrolled patients in accordance with the recent guidelines and recommendations, could represent one of the first proofs of the clinical effectiveness of early oral immunonutrition in cancer patients undergoing CT-RT and could stimulate further large randomized trials, potentially resulting in the improvement of supportive care quality.
TRIAL REGISTRATION
This study is registered on ClinicalTrials.gov Identifier: NCT04611113.
背景
营养支持，包括营养咨询和口服营养补充剂（ONS），已被建议在头颈部（H&N）癌症患者中尽早提供。关于免疫营养在H&N癌症患者放化疗（CT-RT）期间疗效的现有证据有限，在一些次要终点方面呈阳性，但仍然不足，特别是在毒性和治疗耐受性方面。我们假设，与标准的高热量高蛋白营养混合剂相比，在营养咨询之外，早期系统地提供含有免疫营养成分（Impact）的高蛋白高热量ONS混合物，可能对接受CT-RT的H&N癌症患者有益。因此，我们设计了本研究，以评估与等氮标准混合剂相比，早期系统地提供富含免疫营养成分的ONS对接受CT-RT的H&N癌症患者在治疗耐受性、毒性和反应、体重、身体成分、蛋白质热量摄入、生活质量（QoL）、疲劳、肌肉力量和免疫谱方面的疗效。
方法
这是一项务实的、双中心的、随机（1:1）、平行组、开放标签、对照的试点临床试验。
讨论
仍需做出许多努力来提高肿瘤学中营养支持的疗效。免疫营养在H&N癌症患者中也是一种有前景的方法，但关于其在CT-RT期间改善临床结局的疗效证据仍不确凿。本试点研究按照最新指南和建议保证了对所有入组患者尽早进行营养评估和支持，可能是早期口服免疫营养对接受CT-RT的癌症患者临床有效性的首批证据之一，并可能刺激进一步的大型随机试验，有可能提高支持性护理质量。
试验注册
本研究已在ClinicalTrials.gov上注册，标识符：NCT04611113。
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