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Goal-directed Enteral Nutritional Perioperative Management

RecruitingNAAges 18 Years - 80 YearsAllCancer Institute and Hospital, Chinese Academy of…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18-80 years old; 2. ECOG PS 0\~1; 3. NRS 2002 score ≥3; 4. Malnutrition diagnosed according to the GLIM criteria; 5. Histopathologically confirmed as esophageal squamous cell carcinoma; 6. Primary tumors located in thoracic esophagus; 7. Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by a multidisciplinary team; 8. 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; 9. Informed consent for random assignment and completion of the protocol. Exclusion Criteria: 1. NRS 2002 score \< 3; 2. Upfront surgery without neoadjuvant treatment; 3. Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®; 4. Receiving any other nutritional support during the study; 5. Unable to consume nutrition orally or receive it through tube feeding before surgery; 6. History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ; 7. 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); 8. Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism; 9. Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents 10. History of known allergy to any component of ORAL IMPACT®; 11. 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; 12. Refuse to sign the consent or unable to follow the study protocol; 13. Inappropriate to participate in this study judged by investigators.
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What it tests

  • Goal-directed EN therapy
  • Conventional EN therapy
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Where

17 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
Anyang Cancer Hospital
Anyang, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Henan Cancer Hospital
Zhengzhou, China
Huai'an First People's Hospital
Huai'an, China
Jiangsu Cancer Hospital
Nanjing, China

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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