Assessing Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival
NCT ID: NCT03676478
Last Updated: 2025-12-10
Study Results
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Basic Information
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TERMINATED
NA
239 participants
INTERVENTIONAL
2019-03-25
2025-12-02
Brief Summary
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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.
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Detailed Description
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This postoperative weight loss has a direct relationship with impaired survival. Therefore, reversing or at least stabilizing the postoperative weight loss might improve survival. The link between weight loss and impaired survival is found in the concept of sarcopenia, the breakdown of muscle fibers. Indeed, by losing muscle strength, patients become too weak for general tasks like bathing, putting clothes on or shopping. In a more pronounced stage, loss of muscle mass is responsible for impaired recovery and eg. the inability to fight against respiratory infections due to lack of cough power.
A logical reaction would therefore be to maximize caloric intake in the peri- and postoperative setting. One could therefore implement extra caloric intake as early as possible in the postoperative track in order to improve recovery. This has been up to now been advocated by scientific organisations like ESPEN (European Society for Clinical Nutrition and Metabolism) by spreading their guidelines on postoperative nutrition.
In contrast, within the field of intensive care and nutrition, discussion has risen about timing of feeding. The focus here shifted in the direction of postponing nutrition to a later stage in the recovery of a sick patient, rather than initiate feeding too soon. Through fundamental research, the concept of impaired autophagy at muscular level in case of early feeding was put forward as underlying mechanism. Muscle cells get swollen and their interlinking structure gets disturbed, resulting in decreased function. The muscle loss itself is triggered by the initial inflammatory storm that these patients go through when their lives are at stake at admission on the ICU. Early energy suppletion seems to aggravate this process even more. This cascade negatively influences recovery. This finding led in our own institution to postpone feeding of patients at the ICU until one week after admission, in order to minimize muscle tissue loss.
The investigators consider the experience in ICU patients as a proof of concept of the postoperative aggravation of sarcopenia in esophageal cancer patients. As patients following esophagectomy are also confronted with a similar catecholamin storm and insulin resistance, they could also be considered to suffer from similar processes that inhibit recovery as patients at the ICU.
The main research hypothesis is therefore that relative energy restriction following surgery would result in better qualitative muscle tissue, in comparison to patients that receive early enteral nutritional support. By doing so, the researchers assume to minimize autophagy at muscular level, resulting in better function and ultimately also in better postoperative recovery. Ultimately, this limitation of muscle loss most likely will have a beneficial effect on survival.
The primary outcome parameter, improvement of muscle function, will be assessed by means of a 6 minute walk test. Apart from this test, several side measurements will be performed - a nutrition diary, activity assessment by means of a MoveMonitor sensor, bio-impedance measurement, quantitive evaluation of muscle mass by CT, qualitative evaluation of muscle quality by muscle biopsy, quality-of-life-questionnaires and continous monitoring of glucose levels during enteral feeding will give the researchers more insight in the underliying mechanisms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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start enteral support @ POD1
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.
No interventions assigned to this group
delayed start enteral support @ POD5
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.
delayed start enteral support @ POD5
instead of caloric suppletion, participants will receive mls of water over the jejunostomy feeding tube daily equivalent to the rate of increase of infusion of the control group as to preserve the same amount of fluid administration through the GI route as the control group.
This is continued until POD5 12.00h when enteral feeding is started according to the incremental regimen as defined for the SOC group. During the intervention, water is used as to maximize stimulation of the enteral route, however without giving nutritional support and need to prolong iv-infusion for maintaining the fluid balance in the participants. Also subjects in this interventional arm will end up with a caloric suppletion of 1.000kCal/24h by the end of postoperative day 7.
Interventions
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delayed start enteral support @ POD5
instead of caloric suppletion, participants will receive mls of water over the jejunostomy feeding tube daily equivalent to the rate of increase of infusion of the control group as to preserve the same amount of fluid administration through the GI route as the control group.
This is continued until POD5 12.00h when enteral feeding is started according to the incremental regimen as defined for the SOC group. During the intervention, water is used as to maximize stimulation of the enteral route, however without giving nutritional support and need to prolong iv-infusion for maintaining the fluid balance in the participants. Also subjects in this interventional arm will end up with a caloric suppletion of 1.000kCal/24h by the end of postoperative day 7.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
90 Years
ALL
No
Sponsors
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Research Foundation Flanders
OTHER
Kom Op Tegen Kanker
OTHER
KU Leuven
OTHER
University Hospital, Gasthuisberg
OTHER
Responsible Party
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Hans Van Veer, MD
MD, FEBS-OGS
Principal Investigators
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Philippe Nafteux, MD, PhD
Role: STUDY_CHAIR
Department of Thoracic Surgery
Lieven P Depypere, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Thoracic Surgery
Michaël Casaer, MD, PhD
Role: STUDY_CHAIR
Department of Intensive Care Medicine
Hans GL Van Veer, MD
Role: STUDY_DIRECTOR
Department of Thoracic Surgery
Locations
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University Hospitals Leuven, dept. of Thoracic Surgery
Leuven, , Belgium
Countries
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References
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Van 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.
Casaer 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.
Willcutts 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.
Low 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.
Rabinovich 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.
Bosy-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.
Leelarathna L, Wilmot EG. Flash forward: a review of flash glucose monitoring. Diabet Med. 2018 Apr;35(4):472-482. doi: 10.1111/dme.13584. Epub 2018 Feb 27.
Goodpaster BH, Kelley DE, Thaete FL, He J, Ross R. Skeletal muscle attenuation determined by computed tomography is associated with skeletal muscle lipid content. J Appl Physiol (1985). 2000 Jul;89(1):104-10. doi: 10.1152/jappl.2000.89.1.104.
Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.
Tarnopolsky MA, Pearce E, Smith K, Lach B. Suction-modified Bergstrom muscle biopsy technique: experience with 13,500 procedures. Muscle Nerve. 2011 May;43(5):717-25. doi: 10.1002/mus.21945. Epub 2011 Apr 1.
Other Identifiers
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2018-002891-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
116000000382
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
T002018N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
S61665
Identifier Type: -
Identifier Source: org_study_id
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