Esophageal CancerEFECTSNCT03676478
Assessing Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival
A study testing delayed start enteral support @ POD5 in people with Esophageal Cancer and Nutrition Aspect of Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophageal Cancer, Nutrition Aspect of Cancer, Postoperative Complications
- What is being tested?
- delayed start enteral support @ POD5
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Mar 2019to 2 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven, dept. of Thoracic Surgery
Leuven, 3000
About this study
Official title: Assessing the Influence of Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival
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.
Read the detailed description
Patients suffering from oesophageal cancer are known to suffer from important weight loss preoperatively, due to dysphagia attributed to the growing tumour. Postoperatively, the challenge of maintaining weight is even more important given the new way of eating through the gastric conduit that replaces the oesophagus. They often also need to tackle dysphagia caused by an anastomotic stricture and overcome the physiological stress of the operation. As a consequence, almost all patients are confronted with postoperative weight loss. Obviously, patients with a low preoperative weight do not have a lot of reserve and are thus even more at risk of becoming anorectic in the postoperative setting.
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
- Esophageal Cancer, Nutrition Aspect of Cancer, Postoperative Complications, Muscle Weakness, Sarcopenia, Jejunostomy; Complications
- Being tested
- delayed start enteral support @ POD5
- Medical subject headings
- Esophageal Neoplasms, Postoperative Complications, Muscle Weakness, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed start enteral support @ POD5Other
Also called delayed start / caloric restriction
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.
| Study group | Role | What they receive |
|---|---|---|
| start enteral support @ POD1 | No intervention | 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. |
| delayed start enteral support @ POD5 | Active comparator | 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. Receives: Other: delayed start enteral support @ POD5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional recovery (6mWD - 6-minute Walked Distance)
detect a difference in walked distance evaluated by means of a 6-minute walk test
Measured: 5±1 weeks postoperative
Secondary outcomes (2)
Days alive outside hospital
number of days alive outside hospital from randomisation until POD90, divided by the number of postoperative days excludng admission days for perioperative chemotherapy (max: 90 days)
Measured: 90 days postoperative
Global Health status score
General Health Related Quality of Life evaluated by means of participant responses on the European Organisation for Research on the Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer QLQ-C30 (generic cancer questionnaire) and Quality of Life Questionnaire QLQ-OES18 (oesophageal cancer disease-specific questionnaire, as an adjoint to the more generic cancer cancer questionnaire).
Scores are expressed in 4-point Likert scales from 1 to 4; higher score equals worser outcomes.
Measured: 5+/-1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start25 Mar 2019
- Primary completion25 May 2025
- Study completion2 Dec 2025
Why it stopped: halted prematurely on the occasion of a planned sample size reestimation after 200 randomised patients during which an unexpected futility finding was demonstrated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded (for outcome), open label, prospective, randomized, controlled, parallel-group designed interventional study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, Kom Op Tegen Kanker, KU Leuven
- Responsible party
- Principal investigator, Hans Van Veer, MD, University Hospital, Gasthuisberg
- Investigators
- Philippe Nafteux, MD, PhD, Study chair, Department of Thoracic SurgeryLieven P Depypere, MD, PhD, Principal investigator, Department of Thoracic SurgeryMichaël Casaer, MD, PhD, Study chair, Department of Intensive Care MedicineHans GL Van Veer, MD, Study director, Department of Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676478
- Sponsor's protocol ID
- S61665
- Other IDs
- 2018-002891-41, 116000000382, T002018N, 2018
- Acronym
- EFECTS
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2018
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25564215Casaer 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.
PubMed 21714640Willcutts 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.
PubMed 26779983Low 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.
PubMed 25607756Rabinovich 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.
PubMed 23397303Bosy-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.
PubMed 23299866Leelarathna 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.
PubMed 29356072Goodpaster 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.
PubMed 10904041Martin 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.
PubMed 23530101Tarnopolsky 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.
PubMed 21462204
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Influence of Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival
- ClinicalTrials.gov ID
- NCT03676478
- Acronym / sponsor ID
- EFECTS / S61665
- Conditions
- Esophageal Cancer, Nutrition Aspect of Cancer, Postoperative Complications, Muscle Weakness, Sarcopenia, Jejunostomy; Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: halted prematurely on the occasion of a planned sample size reestimation after 200 randomised patients during which an unexpected futility finding was demonstrated
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, Kom Op Tegen Kanker, KU Leuven
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients suffering from oesophageal cancer are known to suffer from important weight loss preoperatively, due to dysphagia attributed to the growing tumour. Postoperatively, the challenge of maintaining weight is even more important given the new way of eating through the gastric conduit that replaces the oesophagus. They often also need to tackle dysphagia caused by an anastomotic stricture and overcome the physiological stress of the operation. As a consequence, almost all patients are confronted with postoperative weight loss. Obviously, patients with a low preoperative weight do not have a lot of reserve and are thus even more at risk of becoming anorectic in the postoperative setting.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded (for outcome), open label, prospective, randomized, controlled, parallel-group designed interventional study
| Arm | Type | Receives |
|---|---|---|
| start enteral support @ POD1 | No intervention | –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. |
| delayed start enteral support @ POD5 | Active comparator | Other: delayed start enteral support @ POD5As 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delayed start enteral support @ POD5Also: delayed start / caloric restrictioninstead 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 | delayed start enteral support @ POD5 |
Primary outcome
Functional recovery (6mWD - 6-minute Walked Distance)
Time frame: 5±1 weeks postoperative
detect a difference in walked distance evaluated by means of a 6-minute walk test
2 secondary outcomes
Days alive outside hospital
Time frame: 90 days postoperative
Global Health status score
Time frame: 5+/-1 week postoperative
Results and safety
The study was stopped early (reason given: halted prematurely on the occasion of a planned sample size reestimation after 200 randomised patients during which an unexpected futility finding was demonstrated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 25564215Van 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.
- Background: PubMed 21714640Casaer 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.
- Background: PubMed 26779983Willcutts 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.
- Background: PubMed 25607756Low 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.
- Background: PubMed 23397303Rabinovich 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.
- Background: PubMed 23299866Bosy-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.
- Background: PubMed 29356072Leelarathna 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.
- Background: PubMed 10904041Goodpaster 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.
- Background: PubMed 23530101Martin 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.
- Background: PubMed 21462204Tarnopolsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Nafteux, MD, PhD study chair
Department of Thoracic Surgery
Lieven P Depypere, MD, PhD principal investigator
Department of Thoracic Surgery
Michaël Casaer, MD, PhD study chair
Department of Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delayed start enteral support @ POD5 in people with Esophageal Cancer and Nutrition Aspect of Cancer, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: halted prematurely on the occasion of a planned sample size reestimation after 200 randomised patients during which an unexpected futility finding was demonstrated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recovery (6mWD - 6-minute Walked Distance) (time frame: 5±1 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676478, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.