Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 17
- 主要终点
- Rate of unplanned hospital admissions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years old;
- •ECOG PS 0~1;
- •NRS 2002 score ≥3;
- •Malnutrition diagnosed according to the GLIM criteria;
- •Histopathologically confirmed as esophageal squamous cell carcinoma;
- •Primary tumors located in thoracic esophagus;
- •Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by a multidisciplinary team;
- •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;
- •Informed consent for random assignment and completion of the protocol.
排除标准
- •NRS 2002 score < 3;
- •Upfront surgery without neoadjuvant treatment;
- •Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
- •Receiving any other nutritional support during the study;
- •Unable to consume nutrition orally or receive it through tube feeding before surgery;
- •History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
- •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);
- •Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;
- •Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents
- •History of known allergy to any component of ORAL IMPACT®;
- •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;
- •Refuse to sign the consent or unable to follow the study protocol;
- •Inappropriate to participate in this study judged by investigators.
结局指标
主要结局
Rate of unplanned hospital admissions
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Body mass index (BMI)(Randomization to three months after surgery)
- Rate of postoperative non-pulmonary complications(Randomization to three months after surgery)
- Rate of pathologic complete response (pCR)(Randomization to three months after surgery)
- Disease-free survival (DFS)(Randomization to five years)
- Rate of R0 resection(Randomization to three months after surgery)
- Scale of health-related quality of life (HRQOL)(Randomization to three months after surgery)
- Level of serum prealbumin(Randomization to three months after surgery)
- Rate of treatment-related adverse events (TRAEs)(Randomization to three months after surgery)
- Lean body mass(Randomization to three months after surgery)
研究者
YIN LI
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences