Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy
Hecheng Li M.D., Ph.D
244 participants
Nov 10, 2020
INTERVENTIONAL
Conditions
Summary
This randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.
Eligibility
Inclusion Criteria6
- Histologically confirmed esophageal cancer
- Staging as cT2N0M0 with high-risk lesions (lymphovascular invasion, ≥3cm, poorly differentiated) / cT1b-2N+M0 / cT3-4aN0-3M0 with the need of neoadjuvant therapy before radical esophagectomy
- Tolerance with oral intake (at least fluid diet)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Body Mass Index (BMI) ≥ 18.5 kg/m2 before recruitment
- Patient's approval and written informed consent
Exclusion Criteria8
- Expected survival time less than 6 months
- Complete dysphagia
- Pregnant or breast-feeding women
- Unable to obey the interventions because of any reasons
- Serious co-morbidities (cardiac, pulmonary, liver, kidney, brain, hematologic, endocrine and other diseases) in patients who cannot tolerate neoadjuvant therapy and/or surgery
- History of previous thoracic or abdominal surgery
- History of other malignant tumor (previous or current)
- Patients with primary small cell carcinoma of the esophagus
Interventions
Preoperative immunonutrition includes an omega-3 fatty-acid enriched enteral nutritional emulsion given by oral intake, nasogastric feeding tube or jejunostomy 600ml per day, lasting for the whole period of neoadjuvant chemoradiation. Meanwhile, oral intake is encouraged to reach 25-30kcal/kg through regular food.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT04513418