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

Esophageal Neoplasms Clinical Trial

— POINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513418
• Other study ID #: RTS-011
• Status: Recruiting
• Phase: Phase 3
• Start date: November 10, 2020
• Est. completion date: December 2028

Study information

• Verified date: May 2022
• Source: Ruijin Hospital
• Contact: Hecheng Li, PhD, MD
• Phone: 00862164370045
• Email: lihecheng2000[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: December 2028
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai	Shanghai
China	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Hecheng Li M.D., Ph.D	Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai Chest Hospital, Shanghai East Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Zhongshan Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Completion rate of neoadjuvant therapy and esophagectomy		2-3 months before surgery
Secondary	Adverse events during neoadjuvant chemoradiotherapy		2-3 months before surgery
Secondary	Pathological complete response rate (pCR)		2-3 months before surgery
Secondary	Blood loss		At operation day
Secondary	Duration of surgery		At operation day
Secondary	Rate of surgery-related complications	Conversion to open surgery, recurrent nerve injury, cardiac and cerebrovascular accident	At operation day
Secondary	Length of hospital stay		Postoperative in-hospital stay
Secondary	Hospitalization costs		Postoperative in-hospital stay
Secondary	30-day and 90-day mortality		Up to 90 days after surgery
Secondary	Weight loss		From neoadjuvant chemoradiotherapy to 6 months after surgery
Secondary	Change in PG-SGA score after surgery		From neoadjuvant chemoradiotherapy to 6 months after surgery
Secondary	Change in biochemical indicators after surgery	WBC, hemoglobin, albumin, CRP, TNF-a, interleukins, IgA, IgG, IgM, fasting blood-glucose	From neoadjuvant chemoradiotherapy to 6 months after surgery
Secondary	Score of EORTC QLQ-C30 and OES-18 scale	Quality of life	1-year, 3-year, and 5-year after surgery
Secondary	Long-term survival	Overall survival (OS) and progression-free survival (PFS)	1-year, 3-year, and 5-year after surgery