Clinical trial · Interventional
Goal-directed Enteral Nutritional Perioperative Management
Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagus Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional EN therapy | Dietary Supplement | — | UNRESOLVED |
| Goal-directed EN therapy | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Goal-directed enteral nutritional therapy
- description
- 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.
- interventionNames
- Dietary Supplement: Goal-directed EN therapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional enteral nutritional therapy
- description
- The participants will be administered with an unsupervised and liberal nutritional support. The EN regimens will not include ORAL IMPACT®.
- interventionNames
- Dietary Supplement: Conventional EN therapy
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available