Goal-directed Enteral Nutritional Perioperative Management

Not Applicable

Recruiting

• Conditions: Esophagus Cancer

• Registration Number: NCT06510543
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2024-03-30
• Study First Submitted: 2024-06-18
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-14
• Last Update Submitted: 2024-07-14
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-08-30
• Study Completion: 2031-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Aged 18-80 years old;
2. ECOG PS 0~1;
3. NRS 2002 score ≥3;
4. Malnutrition diagnosed according to the GLIM criteria;
5. Histopathologically confirmed as esophageal squamous cell carcinoma;
6. Primary tumors located in thoracic esophagus;
7. Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by a multidisciplinary team;
8. Neoadjuvant therapy will be administered, which may entail preoperative chemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such as anti-PD-1/PD-L1;
9. Informed consent for random assignment and completion of the protocol.

Exclusion Criteria

1. NRS 2002 score < 3;
2. Upfront surgery without neoadjuvant treatment;
3. Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
4. Receiving any other nutritional support during the study;
5. Unable to consume nutrition orally or receive it through tube feeding before surgery;
6. History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
7. Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit of normal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit of normal);
8. Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;
9. Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents
10. History of known allergy to any component of ORAL IMPACT®;
11. Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test at baseline or not using a reliable and appropriate contraceptive method;
12. Refuse to sign the consent or unable to follow the study protocol;
13. Inappropriate to participate in this study judged by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of unplanned hospital admissions	Randomization to three months after surgery	Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute hospital admission.
Rate of postoperative pulmonary complications	Randomization to three months after surgery	According to the Esophagectomy Complications Consensus Group (ECCG) standardization of complications reporting, pulmonary complications include pneumonia, pleural effusion, pneumothorax, atelectasis, mucous plugging, respiratory failure, acute respiratory distress syndrome, acute aspiration, tracheobronchial injury, and prolonged air-leak.
Rate of unplanned ICU admission	Randomization to three months after surgery	Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute ICU admission.
Overall survival	Randomization to five years	The time from randomization to death. Any patients lost to follow up or still alive at the time of evaluation are censored.

Secondary Outcome Measures

Name	Time	Method
Body mass index (BMI)	Randomization to three months after surgery	A person's weight in kilograms divided by the square of height in meters.
Rate of postoperative non-pulmonary complications	Randomization to three months after surgery	Non-pulmonary complications according to the ECCG standardization of complications reporting.
Rate of pathologic complete response (pCR)	Randomization to three months after surgery	The absence of invasive/in situ cancer in the resected esophagus and regional lymph nodes.
Disease-free survival (DFS)	Randomization to five years	Defined as the proportion of patients without disease progression or death.
Rate of R0 resection	Randomization to three months after surgery	Distance between tumor and the circumferential resection margin (CRM) more than 1 mm.
Scale of health-related quality of life (HRQOL)	Randomization to three months after surgery	A state of complete physical, mental and social well-being, and not merely the absence of disease and infirmity evaluated by EORTC OES18、EQ-5D、FAACT.
Level of serum prealbumin	Randomization to three months after surgery	Prealbumin, also known as transthyretin, has a half-life in plasma of ∼2 days, much shorter than that of albumin. Prealbumin is therefore more sensitive to changes in protein-energy status than albumin, and its concentration closely reflects recent dietary intake rather than overall nutritional status.
Rate of treatment-related adverse events (TRAEs)	Randomization to three months after surgery	An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Lean body mass	Randomization to three months after surgery	The weight of the body minus the⁣ fat content, representing the amount of⁣ muscle, bone, and organs in the body.

Trial Locations

Locations (17)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Daping Hospital, Third Affiliated Hospital of Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Anyang Cancer Hospital; 🇨🇳 Anyang, Henan, China

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Huai'an First People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

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