NCT06510543

Goal-directed Enteral Nutritional Perioperative Management

Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.

Detailed description

Severe malnutrition is a significant risk factor for postoperative complications in esophageal cancer patients. Early oral nutritional supplementation after surgery can prevent weight loss and improve quality of life. The EFFORT trial showed that individual-based enteral nutrition support reduced complications, extended 1-year survival, and improved quality of life. This study aims to assess the safety and effectiveness of individualized perioperative nutrition support guided by daily energy targets in esophageal cancer patients at nutritional risk. It also seeks to determine if supplementing immunonutrition can effectively reduce postoperative complications. This study was conducted as a multicenter, open-label, randomized, controlled phase 3 trial. The experiment group was administered goal-directed enteral nutritional therapy, while the control group received conventional enteral nutritional therapy. The study observed the participants' major pulmonary and other complications within 90 days post-surgery and nutritional status, disease-free survival (DFS), and overall survival (OS) in both groups.

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Goal-directed EN therapy	The participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal.
DIETARY_SUPPLEMENT	Conventional EN therapy	The participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition).

Timeline

• Start date: 2024-03-30
• Primary completion: 2026-08-30
• Completion: 2031-05-30
• First posted: 2024-07-19
• Last updated: 2024-07-19

Locations

17 sites across 1 country: China