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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
400
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.
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).
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGRate of postoperative pulmonary complications
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.
Time frame: Randomization to three months after surgery
Rate of unplanned hospital admissions
Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute hospital admission.
Time frame: Randomization to three months after surgery
Rate of unplanned ICU admission
Any admission (all cause) for an unforeseen or unplanned (non-elective) cause within 90 days of discharge from an index acute ICU admission.
Time frame: Randomization to three months after surgery
Overall survival
The time from randomization to death. Any patients lost to follow up or still alive at the time of evaluation are censored.
Time frame: Randomization to five years
Rate of postoperative non-pulmonary complications
Non-pulmonary complications according to the ECCG standardization of complications reporting.
Time frame: Randomization to three months after surgery
Level of serum prealbumin
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.
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Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGAnyang Cancer Hospital
Anyang, Henan, China
RECRUITINGFirst Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHuai'an First People's Hospital
Huai'an, Jiangsu, China
RECRUITINGJiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGJiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITING...and 7 more locations
Time frame: Randomization to three months after surgery
Body mass index (BMI)
A person's weight in kilograms divided by the square of height in meters.
Time frame: Randomization to three months after surgery
Lean body mass
The weight of the body minus the fat content, representing the amount of muscle, bone, and organs in the body.
Time frame: Randomization to three months after surgery
Rate of treatment-related adverse events (TRAEs)
An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Time frame: Randomization to three months after surgery
Rate of R0 resection
Distance between tumor and the circumferential resection margin (CRM) more than 1 mm.
Time frame: Randomization to three months after surgery
Rate of pathologic complete response (pCR)
The absence of invasive/in situ cancer in the resected esophagus and regional lymph nodes.
Time frame: Randomization to three months after surgery
Disease-free survival (DFS)
Defined as the proportion of patients without disease progression or death.
Time frame: Randomization to five years
Scale of health-related quality of life (HRQOL)
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.
Time frame: Randomization to three months after surgery