Clinical trial · Interventional
Assessing Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival
Assessing the Influence of Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): halted prematurely on the occasion of a planned sample size reestimation after 200 randomised patients during which an unexpected futility finding was demonstrated
Summary
Brief summary (as posted)
The surgical stress of an esophagectomy causes a detrimental impact on the physiological response of the body. In this perspective, one could question whether the current feeding regimens of starting early nutritional support at postoperative day (POD) 1 have a similar negative impact on the muscle mass as documented in critically ill patients. This study will introduce relative starvation in the early days following esophagectomy compared to the current regimen of early enteral nutritional support. The research team aims to investigate whether the negative impact on muscle mass and muscle function might be reduced, which should result in enhanced postoperative recovery. The final result of the study will be a well-documented and scientifically substantiated nutritional regimen for patients who underwent an esophagectomy for cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Jejunostomy; Complications | — | UNRESOLVED | — |
| Muscle Weakness | — | UNRESOLVED | — |
| Nutrition Aspect of Cancer | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Sarcopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| delayed start enteral support @ POD5 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- start enteral support @ POD1
- description
- The standard of care (SoC) in our department consists of enteral nutritional support of maximum 1000 kilocalories (kCal) through a peroperatively placed jejunostomy feeding tube started at POD 1. Oral caloric intake is resumed at POD 4.
- type
- ACTIVE_COMPARATOR
- label
- delayed start enteral support @ POD5
- description
- As study intervention (INT), a period of caloric restriction is set by starting the enteral nutritional support later, at POD 5. Oral caloric intake is resumed at POD 4, similarly as in the control group. This intervention results in a relative caloric defect of more than 4.000 kCal in the immediate postoperative course.
- interventionNames
- Other: delayed start enteral support @ POD5
Primary outcomes (1)
- measure
- Functional recovery (6mWD - 6-minute Walked Distance)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Candidates for surgical resection with a curative intent, admitted to our Department. * Able to understand the study information in Dutch or French and tasks related to the study measurements provided by the researchers. * Able to consent. * Patients with cancer of the gastroesophageal junction (GEJ), distal, mid- and proximal thoracic esophagus. * Patients with early as well as advanced clinical stage esophageal cancer: from clinical stages cT1N0 over cT2+ N+ or cT3 Nx after neo-adjuvant therapy or at the time of staging as a candidate for primary surgery. * Histology preop: Squamous or adenocarcinoma. * Patients must undergo at least two-field lymphadenectomy; three-field lymphadenectomy if deemed necessary by the clinical team is not a contraindication for inclusion. * All access: (robotic assisted) minimal invasive (thoracoscopy \& laparoscopy) approach, left thoraco-abdominal incision, hybrid esophageal resection or R thoracotomy + laparotomy * Partial or subtotal esophagectomy. * Reconstruction by gastric conduit. * All anastomoses (intrathoracic or cervical). * Women of child bearing age with esophageal cancer can be included. Exclusion Criteria: * Patients in a definitive chemoradiation protocol, or undergoing rescue resection following definitive chemoradiotherapy. * Patients expected to die within 12 hours (=moribund patients). * Patients transferred from another institute after esophageal resection with an established nutritional therapy. * Patients with a cT4b tumor after neo-adjuvant therapy. * Patients who are at the time of surgery deemed unresectable or found to be unresectable during surgery. * Patients with a R2-resection. * Patients with metastasis at the time of clinical staging. * Patients undergoing transhiatal resection of the esophagus. * Patients undergoing total gastrectomy * Patients undergoing an esophageal resection or esophageal bypass as palliative treatment * Patients with tumors in the cervical esophagus with a distance less than 3cm from the cricopharyngeal sphincter. * Patients with pharyngeal cancer undergoing (laryngo-)pharyngectomy with gastric pull-up * Need for colonic or jejunal interposition * Patients with a second synchronous malignancy * Patients with inflammatory bowel disease (as this might interfere with caloric uptake in the small bowel) * Patients with contra-indications for enteral nutrition. * Patients already participating in a study with a nutritional intervention.
References
Publications (10)
- BACKGROUNDVan Veer H, Moons J, Darling G, Lerut T, Coosemans W, Waddell T, De Leyn P, Nafteux P. Validation of a new approach for mortality risk assessment in oesophagectomy for cancer based on age- and gender-corrected body mass index. Eur J Cardiothorac Surg. 2015 Oct;48(4):600-7. doi: 10.1093/ejcts/ezu503. Epub 2015 Jan 5. PMID 25564215
- BACKGROUNDCasaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29. PMID 21714640
- BACKGROUNDWillcutts KF, Chung MC, Erenberg CL, Finn KL, Schirmer BD, Byham-Gray LD. Early Oral Feeding as Compared With Traditional Timing of Oral Feeding After Upper Gastrointestinal Surgery: A Systematic Review and Meta-analysis. Ann Surg. 2016 Jul;264(1):54-63. doi: 10.1097/SLA.0000000000001644. PMID 26779983
- BACKGROUNDLow DE, Alderson D, Cecconello I, Chang AC, Darling GE, D'Journo XB, Griffin SM, Holscher AH, Hofstetter WL, Jobe BA, Kitagawa Y, Kucharczuk JC, Law SY, Lerut TE, Maynard N, Pera M, Peters JH, Pramesh CS, Reynolds JV, Smithers BM, van Lanschot JJ. International Consensus on Standardization of Data Collection for Complications Associated With Esophagectomy: Esophagectomy Complications Consensus Group (ECCG). Ann Surg. 2015 Aug;262(2):286-94. doi: 10.1097/SLA.0000000000001098. PMID 25607756
- BACKGROUNDRabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, Burtin C, Regueiro EM, Vogiatzis I, Hopkinson NS, Polkey MI, Wilson FJ, Macnee W, Westerterp KR, Troosters T; PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J. 2013 Nov;42(5):1205-15. doi: 10.1183/09031936.00134312. Epub 2013 Feb 8. PMID 23397303
- BACKGROUNDBosy-Westphal A, Schautz B, Later W, Kehayias JJ, Gallagher D, Muller MJ. What makes a BIA equation unique? Validity of eight-electrode multifrequency BIA to estimate body composition in a healthy adult population. Eur J Clin Nutr. 2013 Jan;67 Suppl 1:S14-21. doi: 10.1038/ejcn.2012.160.