Goal-directed Enteral Nutritional Perioperative Management
GENTLEMAN
1 other identifier
interventional
400
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2024
CompletedFirst Submitted
Initial submission to the registry
June 18, 2024
CompletedFirst Posted
Study publicly available on registry
July 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2031
July 19, 2024
July 1, 2024
2.4 years
June 18, 2024
July 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Rate 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.
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.
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.
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.
Randomization to five years
Secondary Outcomes (9)
Rate of postoperative non-pulmonary complications
Randomization to three months after surgery
Level of serum prealbumin
Randomization to three months after surgery
Body mass index (BMI)
Randomization to three months after surgery
Lean body mass
Randomization to three months after surgery
Rate of treatment-related adverse events (TRAEs)
Randomization to three months after surgery
- +4 more secondary outcomes
Study Arms (2)
Goal-directed enteral nutritional therapy
EXPERIMENTALThe 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.
Conventional enteral nutritional therapy
ACTIVE COMPARATORThe participants will be administered with an unsupervised and liberal nutritional support. The EN regimens will not include ORAL IMPACT®.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, 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
Shandong Provincial Hospital
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Changzhi People's Hospital
Changzhi, Shanxi, China
Shanxi Cancer Hospital, Chinese Academy of Medical Sciences
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yin Li, M.D.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 18, 2024
First Posted
July 19, 2024
Study Start
March 30, 2024
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
May 30, 2031
Last Updated
July 19, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share