Assessing Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and… (NCT03676478) | Clinical Trial Compass
TerminatedNot Applicable
Assessing Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival
Stopped: halted prematurely on the occasion of a planned sample size reestimation after 200 randomised patients during which an unexpected futility finding was demonstrated
Belgium239 participantsStarted 2019-03-25
Plain-language summary
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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — can you find out why it ended early, and whether that affects what we know about the safety or effectiveness of the timing of tube feeding after esophageal cancer surgery?
2The trial was studying when to start feeding through a jejunostomy tube after surgery, and measuring recovery using the 6-minute walk distance test — does this kind of nutritional timing approach apply to my specific situation, and is there other completed research I should know about instead?
3Since this study focused on muscle weakness and sarcopenia in esophageal cancer patients after surgery, should we be assessing my muscle strength or nutritional status now, before any surgery, and what feeding plan would you recommend given this trial didn't reach its conclusions?
4Because the trial is terminated and the results may be incomplete or unpublished, is there a different clinical trial or established protocol on post-surgical nutrition support for esophageal cancer that you'd consider a better option for me to explore?
5Given that this trial looked at postoperative complications alongside functional recovery, can you walk me through what the standard approach to jejunostomy feeding timing looks like at this hospital, and how confident you are in that approach given the limited evidence from studies like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.