Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy
NCT ID: NCT04513418
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
244 participants
INTERVENTIONAL
2020-11-10
2028-12-31
Brief Summary
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Detailed Description
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This prospective 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.
The sample size is estimated with the hypothesis that preoperative immunonutrition during the neoadjuvant therapy can reduce postoperative nutrition and immune-related complications after esophagectomy. According to the previously published articles, the required sample size of interventional and control arm (ratio=2:1) was calculated as 137 cases and 69 cases to detect the reduction in related complications from 50% to 30% based on a bilateral significance level (α) of 0.05 and a power of test (1-β) of 0.80. Considering an estimated drop rate of 15%, the minimum sample size of this study is 244 patients, 162 cases in the interventional group and 82 in the control group. After signing the informed consent, every eligible participant will be randomized into either group based on a computer-generated random number. Blinding will not be applied to patients and surgeons due to the difficulty in clinical practice but outcomes assessor will be masked.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Interventional group
Patients receive omega-3 fatty-acid enriched enteral nutritional emulsion during the neoadjuvant chemoradiotherapy. Patients are meanwhile encouraged to intake 25-30kcal/kg through regular food.
Preoperative 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.
Control group
Patients are encouraged to intake 25-30kcal/kg through regular food without supplemental nutritional support before esophagectomy.
No interventions assigned to this group
Interventions
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Preoperative 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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
Zhejiang Cancer Hospital
OTHER
Hecheng Li M.D., Ph.D
OTHER
Responsible Party
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Hecheng Li M.D., Ph.D
Director
Principal Investigators
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Hecheng Li, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Cao Y, Han D, Yang S, Shi Y, Zhao S, Jin Q, Li J, Li C, Zhang Y, Shen W, He J, Wang M, Ji G, Li Z, He Y, Chen Q, Wei W, Chen C, Gong X, Wang J, Tan L, Wang H, Li H. Effects of pre-operative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy: protocol for a multicenter randomized controlled trial (point trial, pre-operative immunonutrition therapy). BMC Cancer. 2022 Jun 13;22(1):650. doi: 10.1186/s12885-022-09721-y.
Other Identifiers
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RTS-011
Identifier Type: -
Identifier Source: org_study_id
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