Clinical nutrition and metabolismClinical nutrition and metabolismКлиническое питание и метаболизм2658-44332782-2974Eco-Vector13922510.17816/clinutr139225Clinical trials protocolПротоколы исследованийResearch ArticleThe impact of perioperative high-protein oral nutrition supplements on postoperative outcomes in primary lung cancer: the protocol of Russian prospective, randomised, multicenter studyВлияние периоперационной высокобелковой нутритивной поддержки на послеоперационные результаты лечения больных первичным раком лёгкого: проект российского проспективного многоцентрового сравнительного исследованияhttps://orcid.org/0000-0002-6025-84203590-9746VolfLarisa Ya.ВольфЛариса Яковлевна
Russian Federation

MD, Cand. Sci. (Med.)

к.м.н.

volf-larisa@mail.ruhttps://orcid.org/0000-0003-0197-77216876-7701ObukhovaOlga A.ОбуховаОльга Аркадьевна
Russian Federation

MD, Cand. Sci. (Med.)

к.м.н.

obukhova0404@yandex.ruhttps://orcid.org/0000-0001-5013-0231EgofarovNail M.ЕгофаровНаиль Мансорович
Russian Federation
nail.egofarov@danone.comKolesnichenkoMariya G.КолесниченкоМария Георгиевна
Russian Federation

MD, Cand. Sci. (Med.)

к.м.н.

maria_2182@mail.ruKirillovYurij V.КирилловЮрий Владимирович
Russian Federation
Yura-1992@mail.ruhttps://orcid.org/0000-0001-6606-606XPovagaSvetlana S.ПовагаСветлана Сергеевна
Russian Federation
povaga1980@mail.ruhttps://orcid.org/0000-0001-9616-0030BelyaevaNatal’ya A.БеляеваНаталья Аркадьевна
Russian Federation
n.makar1973@mail.ru9814-3379GordeevaEkaterina V.ГордееваЕкатерина Владимировна
Russian Federation
simmetria0@mail.ruPerminovYurij V.ПерминовЮрий Викторович
Russian Federation
iuriiperminov88@gmail.comhttps://orcid.org/0000-0002-1819-72066609-6890SkorokhodAndrej A.СкороходАндрей Андреевич
Russian Federation

MD, Cand. Sci. (Med.)

к.м.н.

dr.skorokhod@mail.ruhttps://orcid.org/0000-0001-6228-182X2365-9458NefedovAndrej O.НефёдовАндрей Олегович
Russian Federation

MD, Cand. Sci. (Med.)

к.м.н.

volf-larisa@mail.ruNovitskyDmitrij N.НовицкийДмитрий Николаевич
Russian Federation
dnn1978@gmail.comNutricia LLCООО «Нутриция»National Medical Research Center of OncologyНМИЦ онкологии имени Н.Н. БлохинаMedical Center “Verax-Med” LLCООО «Медицинский центр „Веракс-Мед“»North-Western State Medical UniversityСЗГМУ имени И.И. МечниковаSmolensk Regional Clinical Oncology DispensaryСмоленский областной онкологический клинический диспансерClinical hospital “RZD-Medicine”Клиническая больница «РЖД-Медицина»Moscow Multidisciplinary Center for Palliative CareМосковский многопрофильный центр паллиативной помощиSaint Petersburg Research Institute of PhthisiopulmonologyСанкт-Петербургский НИИ фтизиопульмонологииClinical Oncology DispensaryКлинический онкологический диспансер1904202331052023415182701202324032023Copyright ©; 2023, Eco-VectorCopyright ©; 2023, Эко-Вектор2023Eco-VectorЭко-Векторhttps://creativecommons.org/licenses/by-nc-nd/4.0https://journals.eco-vector.com/2658-4433/article/view/139225

BACKGROUND: Nutritional support, including oral nutrition supplements, is an integral part of anticancer treatment, including during surgical treatment of non-small cell lung cancer. Existing evidence for the effectiveness of nutritional support in this cohort of patients is limited. We suggest that the perioperative administration of a balanced polymeric hypercaloric high-protein enteral nutritional formula by sipping as an additional nutrition can have a positive effect on the results of surgical treatment.

AIMS: 1) to assess the impact of perioperative nutritional support with high-protein oral nutrition supplements on the risk of postoperative complications, postoperative recovery of respiratory functions, nutritional status and quality of life in patients with primary lung cancer; 2) identification of possible side effects and complications when using high-protein high-energy oral nutrition supplements in patients with non-small cell lung cancer.

MATERIALS AND METHODS: Russian prospective, randomised, multicenter low-intervention study of perioperative effect of high-protein nutritional support on postoperative outcomes in the treatment of primary lung cancer with parallel groups, 1:1 randomization. The study will include 114 patients with primary non-small cell lung cancer who are scheduled for surgery. It is expected to provide nutritional support in the perioperative period for 14 days before surgery and for 14 days after it.

CONCLUSION: The present study may become one of the first evidence-based studies confirming the effectiveness of perioperative nutritional support with high-protein mixtures in patients with non-small cell lung cancer and will allow further study of the strategy of nutritional support in this category of patients.

Обоснование. Нутритивная поддержка, в частности сипинг, является неотъемлемой частью противоопухолевого лечения, в том числе при проведении оперативного лечения немелкоклеточного рака лёгких. Существующие доказательства эффективности нутритивной поддержки у этой когорты больных ограничены. Мы предполагаем, что периоперационное назначение сбалансированной полимерной гиперкалорической высокобелковой энтеральной питательной смеси методом сипинга в качестве дополнительного питания может оказать положительное влияние на результаты хирургического лечения.

Цели исследования: 1) оценка влияния периоперационной нутритивной поддержки высокобелковыми смесями на риск развития послеоперационных осложнений, послеоперационное восстановление дыхательных функций, нутритивный статус и качество жизни больных раком лёгких; 2) выявление возможных побочных эффектов и осложнений при применении высокобелкового высокоэнергетического сипинга у больных немелкоклеточным раком лёгких.

Материалы и методы. Планируется проведение российского многоцентрового сравнительного малоинтервенционного исследования влияния периоперационной высокобелковой нутритивной поддержки на послеоперационные результаты лечения первичного рака лёгкого с параллельными группами, рандомизация 1:1. В исследование будет включено 114 больных с впервые выявленным немелкоклеточным раком лёгких, которым планируется проведение оперативного вмешательства. Предполагается проведение нутритивной поддержки в периоперационном периоде в течение 14 дней до хирургического вмешательства и в течение 14 дней после него.

Заключение. Настоящее исследование может стать одним из первых доказательных исследований, подтверждающих эффективность периоперационной нутритивной поддержки высокобелковыми смесями у больных немелкоклеточным раком лёгких и позволит продолжить изучение стратегии проведения нутритивной поддержки у этой категории больных.

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