Status:
RECRUITING
Goal-directed Enteral Nutritional Perioperative Management
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Esophagus Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2031
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06510543
Start Date
March 30 2024
End Date
May 30 2031
Last Update
July 19 2024
Active Locations (17)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
3
Fujian Cancer Hospital
Fuzhou, Fujian, China
4
Anyang Cancer Hospital
Anyang, Henan, China