Goal-directed Enteral Nutritional Perioperative Management

Официальное название

Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management

Обзор

This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.

Подробное описание

Severe malnutrition is a significant risk factor for postoperative complications in esophageal cancer patients. Early oral nutritional supplementation after surgery can prevent weight loss and improve quality of life. The EFFORT trial showed that individual-based enteral nutrition support reduced complications, extended 1-year survival, and improved quality of life. This study aims to assess the safety and effectiveness of individualized perioperative nutrition support guided by daily energy targets in esophageal cancer patients at nutritional risk. It also seeks to determine if supplementing immunonutrition can effectively reduce postoperative complications. This study was conducted as a multicenter, open-label, randomized, controlled phase 3 trial. The experiment group was administered goal-directed enteral nutritional therapy, while the control group received conventional enteral nutritional therapy. The study observed the participants' major pulmonary and other complications within 90 days post-surgery and nutritional status, disease-free survival (DFS), and overall survival (OS) in both groups.

Вмешательства

• Пищевая добавка Goal-directed EN therapy
  The participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal.
• Пищевая добавка Conventional EN therapy
  The participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition).

Первичные конечные точки

• Rate of postoperative pulmonary complications [Срок оценки: Randomization to three months after surgery]
• Rate of unplanned hospital admissions [Срок оценки: Randomization to three months after surgery]
• Rate of unplanned ICU admission [Срок оценки: Randomization to three months after surgery]
• Overall survival [Срок оценки: Randomization to five years]

Вторичные конечные точки (9)

• Rate of postoperative non-pulmonary complications [Срок оценки: Randomization to three months after surgery]
• Level of serum prealbumin [Срок оценки: Randomization to three months after surgery]
• Body mass index (BMI) [Срок оценки: Randomization to three months after surgery]
• Lean body mass [Срок оценки: Randomization to three months after surgery]
• Rate of treatment-related adverse events (TRAEs) [Срок оценки: Randomization to three months after surgery]
• Rate of R0 resection [Срок оценки: Randomization to three months after surgery]
• Rate of pathologic complete response (pCR) [Срок оценки: Randomization to three months after surgery]
• Disease-free survival (DFS) [Срок оценки: Randomization to five years]
• Scale of health-related quality of life (HRQOL) [Срок оценки: Randomization to three months after surgery]

Критерии участия

Критерии включения

• Aged 18-80 years old;
• ECOG PS 0\~1;
• NRS 2002 score ≥3;
• Malnutrition diagnosed according to the GLIM criteria;
• Histopathologically confirmed as esophageal squamous cell carcinoma;
• Primary tumors located in thoracic esophagus;
• Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by a multidisciplinary team;
• Neoadjuvant therapy will be administered, which may entail preoperative chemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such as anti-PD-1/PD-L1;
• Informed consent for random assignment and completion of the protocol.

Критерии исключения

• NRS 2002 score < 3;
• Upfront surgery without neoadjuvant treatment;
• Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
• Receiving any other nutritional support during the study;
• Unable to consume nutrition orally or receive it through tube feeding before surgery;
• History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
• Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit of normal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit of normal);
• Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;
• Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents
• History of known allergy to any component of ORAL IMPACT®;
• Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test at baseline or not using a reliable and appropriate contraceptive method;
• Refuse to sign the consent or unable to follow the study protocol;
• Inappropriate to participate in this study judged by investigators.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 17 центров

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Daping Hospital, Third Affiliated Hospital of Third Military Medical University — Чунцин
• Fujian Cancer Hospital — Фучжоу
• Anyang Cancer Hospital — Anyang
• First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Henan Cancer Hospital — Чжэнчжоу
• Huai'an First People's Hospital — Huai'an
• Jiangsu Cancer Hospital — Нанкин
• … и ещё 9 центров

Идентификаторы

NCT: NCT06510543 · GENTLEMAN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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