RecruitingPhase 3NCT04513418

Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy


Sponsor

Hecheng Li M.D., Ph.D

Enrollment

244 participants

Start Date

Nov 10, 2020

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether giving special nutritional supplements (immune-boosting nutrition) before surgery helps esophageal cancer patients who also need pre-surgery chemotherapy and radiation. **You may be eligible if...** - You have been diagnosed with esophageal cancer confirmed by a biopsy - Your cancer requires treatment with chemotherapy and radiation before surgery - You are able to eat and drink at least a little by mouth - You are between 18 and 75 years old - Your body weight loss is not too severe (less than 20% of normal weight) **You may NOT be eligible if...** - You have severe swallowing difficulties and cannot tolerate oral nutrition - You have other serious medical conditions or a second cancer - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPreoperative immunonutrition

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)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

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NCT04513418


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