Assessing Timing of Enteral Feeding Support in Esophageal Cancer Patients on Muscle functTion and Survival

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.

Conditions

• Esophageal Cancer
• Nutrition Aspect of Cancer
• Postoperative Complications
• Muscle Weakness
• Sarcopenia
• Jejunostomy; Complications

Interventions

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.

Sponsors & Collaborators

• Research Foundation Flanders

  collaborator OTHER

• Kom Op Tegen Kanker

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• University Hospital, Gasthuisberg

  lead OTHER

Principal Investigators

• Philippe Nafteux, MD, PhD · Department of Thoracic Surgery

• Lieven P Depypere, MD, PhD · Department of Thoracic Surgery

• Michaël Casaer, MD, PhD · Department of Intensive Care Medicine

• Hans GL Van Veer, MD · Department of Thoracic Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-25

Primary Completion

2025-05-25

Completion

2025-12-02

Countries

• Belgium

Study Locations