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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
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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.
Esophageal cancer ranks the fourth in mortality and the sixth in incidence among cancers in China according to the latest report of cancer epidemiology. Although the development of neoadjuvant therapy and radical esophagectomy have improved the prognosis of esophageal cancer patients, dysphagia and digestive tract reconstruction can cause malnutrition and infection-related complications. Postoperative enteral and parenteral nutrition have proved to be effective in improving outcomes after esophagectomy. However, whether to provide a preoperative nutritional support for patients with resectable esophageal cancer remains controversial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | 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. |
|
| Control group | No Intervention | Patients are encouraged to intake 25-30kcal/kg through regular food without supplemental nutritional support before esophagectomy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative immunonutrition | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of postoperative nutrition and immune-related complications | Rate of gastrointestinal complications (anastomotic leakage, gastrointestinal dysfunction), metabolic complications (electrolyte disturbances, liver or renal dysfunction) and infectious complications(wound infection, catheter-related infection, pneumonia, sepsis, or other infections requiring antibiotics). | Up to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of neoadjuvant therapy and esophagectomy | 2-3 months before surgery | |
| Adverse events during neoadjuvant chemoradiotherapy | 2-3 months before surgery | |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal residual disease (MRD) | Studies suggest that MRD monitoring through circulating tumor DNA (ctDNA) can predict whether a patient has achieved pCR after neoadjuvant chemoradiotherapy, thereby evaluating the efficacy of the treatment. Therefore, in order to explore whether enteral immunonutrition influences the efficacy of neoadjuvant chemoradiotherapy, we added the exploratory endpoint of MRD detection. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hecheng Li, PhD, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41074192 | Background | Cheng Y, Cao 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, Tan L, Wang H, Shi Y, Li H. Updated protocol of the POINT trial: a multicenter randomized controlled trial investigating effects of preoperative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy. Trials. 2025 Oct 10;26(1):401. doi: 10.1186/s13063-025-09117-w. | |
| 35698100 |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Ningbo Medical Center Lihuili Hospital |
| OTHER_GOV |
| Zhejiang Cancer Hospital | OTHER |
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|
| Pathological complete response rate (pCR) |
| 2-3 months before surgery |
| Blood loss | At operation day |
| Duration of surgery | At operation day |
| Rate of surgery-related complications | Conversion to open surgery, recurrent nerve injury, cardiac and cerebrovascular accident | At operation day |
| Length of hospital stay | Postoperative in-hospital stay |
| Hospitalization costs | Postoperative in-hospital stay |
| 30-day and 90-day mortality | Up to 90 days after surgery |
| Weight loss | From neoadjuvant chemoradiotherapy to 6 months after surgery |
| Change in PG-SGA score after surgery | From neoadjuvant chemoradiotherapy to 6 months after surgery |
| Change in biochemical indicators after surgery | WBC, hemoglobin, albumin, CRP, TNF-α, interleukins, IgA, IgG, IgM, fasting blood-glucose | From neoadjuvant chemoradiotherapy to 6 months after surgery |
| Score of EORTC QLQ-C30 and OES-18 scale | Quality of life | 1-year, 3-year, and 5-year after surgery |
| Long-term survival | Overall survival (OS) and progression-free survival (PFS) | 1-year, 3-year, and 5-year after surgery |
| Before and after neoadjuvant chemoradiotherapy, 7-14 days after surgery |
| Microbiomics analysis | By collecting fecal samples before and after neoadjuvant chemoradiotherapy and utilizing metagenomic sequencing, we aim to investigate the impact of enteral immunonutrition on the gut microbiome distribution in patients with esophageal cancer. | 1 week before neoadjuvant chemoradiotherapy, 2-3 days before surgery |
| Metabolomic analysis | By collecting peripheral blood samples before and after neoadjuvant chemoradiotherapy and utilizing mass spectrometry, we aim to investigate the impact of enteral immunonutrition on the metabolomic distribution in patients with esophageal cancer. | 1 week before neoadjuvant chemoradiotherapy, 2-3 days before surgery |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200030 | China |
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Ningbo Medical Center Lihuili Hospital | Ningbo | Zhejiang | 315048 | China |
| Background |
| 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. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |