Esophageal Cancer Clinical Trial
— EFECTSOfficial 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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | March 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven, dept. of Thoracic Surgery | Leuven |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gasthuisberg | Kom Op Tegen Kanker, KU Leuven, Research Foundation Flanders |
Belgium,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Occurrence of readmission | number of readmissions following primary discharge | assessed upto 1 year postoperative | |
Other | Variation in 6-minute walked distance | Changes in 6-minute walked distances at further time points than the primary parameter | discharge and 90 days postoperative | |
Other | 90-day mortality | status dead or alive following surgery | 90 days postoperative | |
Other | Overall survival | status dead or alive following surgery, after ongoing follow-up for one year | from operation until 1 year postoperative | |
Other | Complications following esophagectomy | complications as defined by the Esophagectomy Complications Consensus Group (ECCG) | assessed upto 1 year postoperative | |
Other | Length of hospital stay | duration of admission, from day of operation until discharge, expressed in days | from day of operation until hospital discharge after esophagectomy, assessed up to 250 days | |
Other | Reasons for readmission | Reasons for readmissions following primary discharge, based on the complications list as defined by the Esophagectomy Complications Consensus Group (ECCG) | from operation, assessed upto 1 year postoperative | |
Other | 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] | from inclusion until 1 year postoperative, every 3 months | |
Other | 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] | from inclusion until 1 year postoperative, every 3 months | |
Other | 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. |
From inclusion until 3 months postoperative | |
Other | Activity related energy expenditure | monitored by means of a Dynaport® accelerometer, expressed in kCal | From inclusion until 3 months postoperative | |
Other | 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 | From inclusion until 3 months postoperative | |
Other | 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 | From inclusion until 3 months postoperative | |
Other | 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 | From inclusion until 3 months postoperative | |
Other | Body composition - phase angle | analysis of body composition by means of Seca Body Composition Analyzer 515. Assessed parameter: phase angle, expressed in ° (degrees) | From inclusion until 3 months postoperative | |
Other | 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) |
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 | |
Other | 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); |
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 | |
Other | 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) |
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 | |
Other | 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 | pre-operative vs. 3 months postoperative | |
Other | Assesment of muscle mass quality | microscopic evaluation and assessment of muscle tissue through muscle biopsy; for seperate consented participants only | biopsy preop, biopsy immediately postintervention (POD8±2 days) and biopsy 5 weeks postop | |
Other | Complications related to feeding catheter | recording of infections, luxations, blockages and reasons for reintervention/replacement/reinsertion | From date of randomization until the date of removal of catheter, assessed up to 12 months | |
Other | Body Mass Index | weight and height will be combined to report BMI in kg/m^2 | from inclusion until 3 months postoperative | |
Other | 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) | From inclusion until 90 days postoperative | |
Other | Satiety hormone levels - Incretins: GIP | Level of variation of satiety hormones between groups, which could influence appetite and weight loss, expressed in pmol/l | From inclusion until 90 days postoperative | |
Other | 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 | From inclusion until 90 days postoperative | |
Other | 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 | From inclusion until 90 days postoperative | |
Other | Levels of Haemoglobin A1c (HbA1c) | Assessment of HbA1c profile over the course of the study, at sober state of participant, expressed in percent | From inclusion until 90 days postoperative | |
Primary | Functional recovery (6mWD - 6-minute Walked Distance) | detect a difference in walked distance evaluated by means of a 6-minute walk test | 5±1 weeks postoperative | |
Secondary | 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) | 90 days postoperative | |
Secondary | 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. |
5+/-1 week postoperative |
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