An interventional study of delayed start enteral support @ POD5 in Esophageal Cancer, Nutrition Aspect of Cancer and Postoperative Complications, sponsored by University Hospital, Gasthuisberg. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University Hospital, Gasthuisberg · Not applicable, Interventional, and Treatment
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Among 41 studies in Esophageal Neoplasms with a site in Belgium — 17 open to participants now, 22 under way, 5 of them phase 3. Esophageal Neoplasms · Belgium.
Among the 41 studies in Esophageal Neoplasms with a site in Belgium, this one is the 15th largest by enrollment of the 32 interventional ones that give a count, is one of 2 that started in 2019, is one of 11 with no phase, and was the 19th registered.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
Browse Esophageal Neoplasms studies →17 of the 41 studies in Esophageal Neoplasms with a site in Belgium are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Belgium, United States, Australia and 21 more countries
Ages 18+
University Hospital, Antwerp · Sites in Belgium, Denmark, France and 3 more countries
Ages 18+
KU Leuven · Sites in Belgium
Ages 18+
Radboud University Medical Center · Sites in Belgium, Netherlands
Ages 18+
KU Leuven · Sites in Belgium
Ages 18–100 · Healthy volunteers
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 8 · Phase 3 7
First in 2002; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 239 is above the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
Median enrollment 198 across the 32 interventional studies, 787 across the 8 observational. Of the 16 that completed or were terminated, 5 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 41 have an industry lead sponsor. The 10 most frequent:
University Hospital, Gasthuisberg is the lead sponsor of 51 studies on the registry; 4 are open to participants now.
University Hospital, Gasthuisberg has 5 studies filed under Esophageal Neoplasms — fewer than ten, so there is no comparison to draw.
4 of the studies in Esophageal Neoplasms with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
| NCT05688176University Hospital, GhentBarrett's Esophagus and Esophageal Adenocarcinoma, Searching for Reliable Diagnostic RNA Plasma-based Biomarkers | 2027-01-31 |
| NCT06238479Eli Lilly and CompanyA Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors | 2027-03 |
| NCT06172478Daiichi SankyoA Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors | 2027-09-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 41 studies in Esophageal Neoplasms with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Other: 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.
Also known as: delayed start / caloric restriction
Functional recovery (6mWD - 6-minute Walked Distance)
detect a difference in walked distance evaluated by means of a 6-minute walk test
Time frame: 5±1 weeks postoperative
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)
Time frame: 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.
Time frame: 5+/-1 week postoperative
Occurrence of readmission
number of readmissions following primary discharge
Time frame: assessed upto 1 year postoperative
Variation in 6-minute walked distance
Changes in 6-minute walked distances at further time points than the primary parameter
Time frame: discharge and 90 days postoperative
90-day mortality
status dead or alive following surgery
Time frame: 90 days postoperative
Overall survival
status dead or alive following surgery, after ongoing follow-up for one year
Time frame: from operation until 1 year postoperative
Complications following esophagectomy
complications as defined by the Esophagectomy Complications Consensus Group (ECCG)
Time frame: assessed upto 1 year postoperative
Length of hospital stay
duration of admission, from day of operation until discharge, expressed in days
Time frame: from day of operation until hospital discharge after esophagectomy, assessed up to 250 days
Reasons for readmission
Reasons for readmissions following primary discharge, based on the complications list as defined by the Esophagectomy Complications Consensus Group (ECCG)
Time frame: from operation, assessed upto 1 year postoperative
Quality of life - Patient Reported Outcome Measurement - EORTC QLQ-C30
quality of life, assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30, probing quality of life in cancer patients by means of 30 questions - Likert Scales \[range 1 to 4, lower is better\]
Time frame: from inclusion until 1 year postoperative, every 3 months
Quality of life - Patient Reported Outcome Measurement - EORTC QLQ-OES18
quality of life, assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-OES18, probing quality of life in oesaphageal cancer patients by means of 18 questions, being more disease specific than the QLQ-C30 questionnaire - Likert Scales \[range 1 to 4, lower is better\]
Time frame: from inclusion until 1 year postoperative, every 3 months
Activity levels - Metabolic Equivalents of Tasks (MET) >3
monitored by means of a Dynaport® accelerometer; duration per assessment period a subject has performed physical activity with a Metabolic Equivalent of Tasks (MET) greater than \>3. MET is a measure for energy expenditure with MET \>3 corresponding to activity more than sedentary state (MET 0 to 3); higher scores means more active.
Time frame: From inclusion until 3 months postoperative
Activity related energy expenditure
monitored by means of a Dynaport® accelerometer, expressed in kCal
Time frame: From inclusion until 3 months postoperative
Body composition - skeletal muscle mass
analysis of body composition by means of Seca Body Composition Analyzer 515. Assessed parameter: skeletal muscle mass, expressed in percentage of body weight
Time frame: From inclusion until 3 months postoperative
Body composition - total body water
analysis of body composition by means of Seca Body Composition Analyzer 515. Assessed parameter: total body water, expressed in percentage of body weight
Time frame: From inclusion until 3 months postoperative
Body composition - total body fat
analysis of body composition by means of Seca Body Composition Analyzer 515. Assessed parameter: total body fat, expressed in percentage of body weight
Time frame: From inclusion until 3 months postoperative
Body composition - phase angle
analysis of body composition by means of Seca Body Composition Analyzer 515. Assessed parameter: phase angle, expressed in ° (degrees)
Time frame: From inclusion until 3 months postoperative
Subcutaneous continuous glycaemia levels in range
effect of permissive caloric restriction in the intervention group (detection of eventual hypoglycaemia) and the effect of nocturnal enteral nutrition on the glucose homeostasis in the whole patient cohort - by means of a flash glucose monitoring system (Freestyle, Abbott). • total time of 'glycaemia level in range', defined as time with (interstitial) glycaemia level between 70mg/dl and 180mg/dl, expressed in total time (minutes/24h)
Time frame: baseline measurement for 10 days (preoperative), from POD0 until 10 days postoperative, 10 days following discharge (between POD8-14 on average), 10 days after stop nutritional support
Subcutaneous continuous glycaemia levels in hypoglycaemia range
effect of permissive caloric restriction in the intervention group (detection of eventual hypoglycaemia) and the effect of nocturnal enteral nutrition on the glucose homeostasis in the whole patient cohort - by means of a flash glucose monitoring system (Freestyle, Abbott). • total time of hypoglycaemia, defined as time with interstitial glycaemia level \< 70mg/dl, expressed in total time (minutes/24h);
Time frame: baseline measurement for 10 days (preoperative), from POD0 until 10 days postoperative, 10 days following discharge (between POD8-14 on average), 10 days after stop nutritional support
Subcutaneous continuous glycaemia levels in hyperglycaemia range during nocturnal enteral nutrition
effect of permissive caloric restriction in the intervention group (detection of eventual hypoglycaemia) and the effect of nocturnal enteral nutrition on the glucose homeostasis in the whole patient cohort - by means of a flash glucose monitoring system (Freestyle, Abbott). • total time of hyperglycaemia, defined as time with interstitial glycaemia level \> 250mg/dl) during nocturnal enteral feeding between 08 pm and 08 am, expressed in total time (minutes/12h)
Time frame: baseline measurement for 10 days (preoperative), from POD0 until 10 days postoperative, 10 days following discharge (between POD8-14 on average), 10 days after stop nutritional support
Assessment of muscle mass quantity
estimation of muscle quantity/sarcopenia via pre- and postoperative available CT-imaging, in comparing mm² of muscle surface area on L3-level image slice
Time frame: pre-operative vs. 3 months postoperative
Assesment of muscle mass quality
microscopic evaluation and assessment of muscle tissue through muscle biopsy; for seperate consented participants only
Time frame: biopsy preop, biopsy immediately postintervention (POD8±2 days) and biopsy 5 weeks postop
Complications related to feeding catheter
recording of infections, luxations, blockages and reasons for reintervention/replacement/reinsertion
Time frame: From date of randomization until the date of removal of catheter, assessed up to 12 months
Body Mass Index
weight and height will be combined to report BMI in kg/m\^2
Time frame: from inclusion until 3 months postoperative
Assessment of nutritional and caloric intake
recording of total caloric intake, proteins and fat (oral intake and administered enteral nutritional support though feeding tube), expressed in kCal, g proteins, g fats, based on feeding diaries (home) and food platter pictures (hospital)
Time frame: From inclusion until 90 days postoperative
Satiety hormone levels - Incretins: GIP
Level of variation of satiety hormones between groups, which could influence appetite and weight loss, expressed in pmol/l
Time frame: From inclusion until 90 days postoperative
Satiety hormone levels - Incretins: GLP-1
Level of variation of satiety hormones between groups, which could influence appetite and weight loss, expressed in pmol/l
Time frame: From inclusion until 90 days postoperative
Levels of fasting blood glycaemia
Assessment of blood glycaemic profile over the course of the study, at sober state of participant, expressed in mg/dl
Time frame: From inclusion until 90 days postoperative
Levels of Haemoglobin A1c (HbA1c)
Assessment of HbA1c profile over the course of the study, at sober state of participant, expressed in percent
Time frame: From inclusion until 90 days postoperative
Plan to share: No
Ran from Mar 2019 to primary completion in May 2025, 74 months.
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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Gasthuisberg