Nutritional supplementation via their jejunostomies for six weeks post hospital discharge, with continued assessment for a further 18 weeks.

No jejunal feeding of patients for six weeks following hospital discharge, with continued assessment for a further 18 weeks

A feeding jejunostomy tube is inserted at the time of surgery to provide enteral nutritional support.

Jejunal feeding

Stephen J Lewis, MBBS, MD

Patients due to undergo surgery for oesophageal and gastric malignancy are often malnourished. Up to 10% of patients preoperative weight may also be lost during the early postoperative period. Following discharge from hospital the mechanics of the surgery leads to a loss of gastric reservoir function, lack of appetite, altered intestinal motility and gastro-oesophageal reflux which usually results in reduced dietary intake and further weight loss. In patients who have undergone upper gastrointestinal resections there are no studies examining the benefit of nutritional supplementation following hospital discharge, however, studies in other groups of surgical patients have failed to show benefit. Despite patients who have undergone upper gastrointestinal surgery being 'at risk' nutritionally, there is no evidence demonstrating the value or not of nutritional supplementation following hospital discharge.

Hypothesis: The postoperative under nutrition seen after upper gastrointestinal surgery will exacerbate the reduced quality of life and fatigue patients' already experience. The investigators hypothesise that improving patient's nutritional intake following hospital discharge will improve their quality of life and fatigue levels.

For patients undergoing upper gastrointestinal (GI) surgery for cancer:

1. Because of the nature of upper gastrointestinal surgery these patients have been shown to suffer undernutrition and weight loss after hospital discharge (up to 3 months) and to a greater extent than other groups of surgical patients. Quality of life and fatigue is a major issue after upper GI surgery.
2. Nutritional supplementation via a jejunostomy after hospital discharge is only done routinely for all patients in 10%, and for selected patients in 20% of United Kingdom (UK) hospitals.
3. Derriford hospital is very unusual in that 85% of patients are given home jejunal feeding.
4. In Devon and Cornwall home enteral nutrition is delivered under contract by Fresenius Kabil (a global health care company).
5. There are no studies of home nutritional supplementation in upper GI surgical patients.
6. Studies of home nutritional supplementation in surgical patients having undergone colorectal surgery have not shown clinical or Quality of Life (QoL) benefit despite weight gain.
7. The process of enteral nutrition may be associated with a reduction in quality of life.
8. There is a need for a clinical trial to establish the benefit of home enteral nutritional supplementation. The results of any such trial may influence the highly variable nutritional present practice and may influence the surgeons desire to place a feeding jejunostomy (or not) at surgery which is associated with clinical complications.

Enteral Feeding in Discharged Patients

Randomised Trial of Enteral Feeding in Patients Discharged From Hospital Following Surgical Resection of an Upper Gastrointestinal Malignancy

The primary outcome will therefore be fatigue as measured by the multidimensional fatigue inventory (MFI-20) score. The MFI-20 is divided into five scales: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue.

We will use the oesophagus specific quality of life (QLQ-OES18) scale. The QLQ-OES18 scale is a disease specific Health-related quality of life (HRQL) questionnaire, designed to examine the influence of upper gastrointestinal pathology on patients and improvement in HRQL following treatment.

Health economic analysis will be based on the EuroQol (EQ 5D) scale 4 (this scale defines health in terms of five dimensions: mobility, self care, usual activities, pain and anxiety).

University Hospital Plymouth NHS Trust

Symptoms and General Pathology

All Conditions

Critical Illness

Disease Attributes

All adult patients ventilated and intubated. These patients should also have enteral nutritional supplement initiated.

Feeding via Nasogastric tube in intubated and ventilated patients

Enteral Feeding

This is a single-center retrospective observational study. The study aimed to look at the enteral feed interruptions in patients who were intubated and ventilated in an oncology intensive care unit. We collected data of the first 60 interruptions in the adult Oncology ICU from 12/12/2022 to 15/10/2023. We only included intubated and ventilated adult patients more than 18 years of age who had nasogastric tube feeding commenced. The data was collected from the electronic patient records. Data collected included demographics, total interruption time per episode of interruption, the reason for the delay, whether the delay could have been avoided, total calories lost, and percentage of calories lost.

Introduction Intensive Care Unit (ICU) patients are often intubated and ventilated. These patients cannot feed themselves orally, so enteral or parenteral nutrition becomes important. Various studies have suggested that meeting their nutritional demand is associated with their short and long-term outcomes. There is also ample evidence that in general ICU's, patients often do not meet their nutritional demands. (1,2) The ICU may often differ in the nature of the patients catered for and also may have very different systems of delivering healthcare provisions. This could have an impact on the patient care provided.

There are several studies suggesting that EN interruptions happen frequently in the ICU. (3,4,5) It is estimated that the EN interruption occurs in more than 85% of the patients for an average of 8-20% of the infusion time. Out of this, it is thought that 23% are avoidable in planned procedures and 65% on all occasions. (6) There is very little data on the duration of the interruptions and those associated with diagnostic procedures.

In this single-centre study, we aim to understand the prevalence of instances of missed feeding within an oncology-focused ICU in intubated patients. We looked at the reason for the delay and estimated the calorie deficit, the duration of the delay and the proportion of patients who met at least 60% of the calorie requirement. This is an important step in developing a feeding protocol to minimize such instances.

Methods This study included all intubated patients admitted to the Intensive Care Unit at the King Faisal Specialist Hospital and Research Centre from December 2022 to November 2023. The inclusion criteria were defined as adult patients above the age of 18 who were intubated and ventilated and started on enteral feeding via nasogastric tube. All patients who were not intubated and under 18 years of age were excluded.

Data will be collected from the electronic patient records. The data collected will be demographics, diagnosis, time the feed was started and stopped, delay in restarting the feed, estimated daily calorie requirement, and calorie deficit. The daily calorie requirement will be estimated using the quick calorie method using kilocalories per kilogram Table1. To estimate the actual calorie intake of the patient, the enteral feeding flowsheet of each patient was monitored, and the total intake will be calculated (mL/hr) for the whole day and based on the type of feed (High calorie, standard etc) it will be multiplied to the total intake to get the actual calorie intake.

Energy requirements Based on Kilocalories per kilogram of body weight condition Energy requirement (kcal/kg) Normal 25-30 (kcal/kg) Obese, critically ill, (BMI\>30) 11-14 (actual body weight) or 22-25 (ideal body weight) Mild stress 30-35 (kcal/kg) Moderate to severe 35-45 (kcal/kg)

Table1. The formula used for estimating calorie requirement. The calorie deficit was calculated from this. The percentage of lost calories will be tabulated, and the number of instances where patients received \>60% or \<60% of the daily requirement will be computed.

The local Research Ethics Committee approved the study. As the study was a non-interventional observational study, a consent waiver was requested and was approved by the ethics committee.

Statistical analysis Demographics will be analyzed for the frequency of distribution. The incidence of feed interruption will be calculated and expressed as median, mean and percentage. The proportion of lost calories and calorie deficit will be calculated in numbers and percentages. The commonest reason for delay, avoidable and unavoidable reasons for feed interruption and the proportion of patients who missed more than 60% of the estimated daily requirement will be estimated using frequencies. Spearmen's correlation rank test will be used to examine the relation between the delay in restarting feed and the lost calories.

Prevalence of Enteral Nutrition Interruption in an Oncology Intensive Care Unit.

Prevalence of Enteral Nutrition Interruption in an Oncology Intensive Care Unit. A Prospective Observational Study

As of now there is no ethical approval and reason to share individual patient details. However, the team will be able to share anonymized dataset if deemed necessary

Estimated daily calorie required was calculated and actual calorie received by the patient was calculated and calorie deficit was calculated from this.

Reasons for stopping and restarting feed was recorded

Delay in restarting the feed in hours were calculated

If the delays were due to factors that could be modified or not modifiable were recorded

King Faisal Specialist Hospital and Research Centre Madinah

Consultant Pulmonary Physician

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Melphalan

Patients put under the protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)

Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)

Enteral Nutrition

Sébastien DAVID

When the digestive tract is functional, learned societies recommend the use of a nutritional support by enteral feeding. Indeed, it has many advantages (maintenance of gut trophicity, reduction of the risk of infection by reducing the incidence of bacterial translocations,...). It has been used for about fifteen years in hematology departments and offers promising results in the context of allogeneic transplantation with prospective trials in progress (NEPHA study). However, its tolerance has not been studied during autologous transplantation. This study aims to assess the success of enteral nutrition in this setting.

In the literature, there are many studies on the nutritional support to be used during allografts, that highlight the superiority of enteral nutrition over parenteral nutrition in terms of reducing co-morbidities.

Enteral nutrition is the nutritional support recommended by learned societies for therapeutic intensification with autograft of autologous hematopoietic cells in hematology. Nevertheless, enteral nutrition presents difficulties in its implementation and failures (refusal of patients, probes vomiting, neutropenic colitis, etc.), requiring the use of parenteral nutrition in case of failure.

In this context, the study proposes to assess the success and effectiveness of enteral nutrition.

Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology

Enteral Nutrition will be considered as a success if : TEI / ER \> 70%. On average until recovery from aplasia (or transfer to the intensive care unit or death).

TEI : Total Energy Intake (per-os + enteral nutrition + glucose solutions) ER : Energy Requirement (assessed patient needs)

All causes of primary or secondary failure that necessitated the cessation of enteral nutrition

All sources of energy intake (per-os, enteral nutrition, parenteral nutrition, glucose solutions) These will be compared to the estimated needs of patients and expressed as a % of coverage of these needs

Blood test carried out on admission and once a week

Weighing carried out on admission and on discharge. Will be used to calculate the percentage of weight loss and assess nutritional status

Measurements performed at admission and at discharge of the patient. Muscular strength is measured using a dynamometer (in kg)

University Hospital, Bordeaux

Digestive System Diseases

Nutritional and Metabolic Diseases

Esophageal Neoplasms

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

Control group = standard of Care regimen: 1000ml = 1000 kCal TPN postop from day 1 until day 7. Oral feeds are started from day 5 onwards if no arguments for clinical leak (cervical anastomosis) or barium swallow is normal. Oral intake consists of regular post gastrectomy diet (building up from fluids over semi-solids to solids) with eventually added high nitrogen energy drinks.

Treatment group: start jejunostomy feeds from day 1, with target of 1000ml = 1000kCal (= 40cc/hour). To equilibrate energy intake during build up fase, Glucose 20% is given at a total cumulative dose taking into account the dose of j-drip, cumulative not exceeding 40cc/hr. Oral feeds are started at the same time as in the control group (reg. day 5) Jejunostomy feeds are then continued for 6 weeks together with oral intake with a continuous energy administration of 1000kCal, and then stopped. After this time, patients should be on regular full diet in both groups. If failure and step-back needed, temporary switch to Glc 20% is done to maintain fluid and calory administration.

Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.

Enteral feeding

Hans Van Veer, MD

Philippe Nafteux, MD

Willy Coosemans, MD, PhD

Johnny Moons, MScN

Paul De Leyn, MD, PhD

It is well known that there is a considerable postoperative weight loss in patients undergoing esophageal resection for cancer.

We believe that this weigh loss can be limited by administering postoperative enteral feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.

We hypothesize that patients undergoing esophageal resection for cancer will have a better overall survival with postoperative additional enteral feeding than when on regular oral diet alone.

Design of the EFECTS Trial

Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival

overall survival at 5 years after esophagectomy

weight loss will be calculated by using age- and gender corrected BMI percentiles

University Hospital, Gasthuisberg

Anesthetics

Anesthetics, Local

Patients randomized to his arm would usually have a small tube is inserted through the nose into the stomach first, so that air can be used to fill the stomach to make it visible on X-ray. A fine needle is then used to inject freezing medicine (local anesthetic) into the skin of the abdomen. Using an x-ray machine for guidance, a puncture is made into the stomach through the frozen skin. The feeding tube is placed through this puncture into the stomach and the tube tip is placed in the small bowel. Once the GJ-tube has been inserted, the tube in the nose is removed.

Patients who are randomized to this arm will usually have a small tube is inserted through the nose into the stomach first, so that air can be used to fill the stomach to make it visible on X-ray. A fine needle is then used to inject freezing medicine (local anesthetic) into the skin of the abdomen. Using an x-ray machine for guidance, a puncture is made through the frozen skin. A small guiding tube or catheter is placed through this puncture into the stomach, and is advanced up the esophagus and out of the mouth. The feeding tube is then pulled into the mouth, down the esophagus, and positioned through the abdomen with its inside tip in the stomach.

Insertion of a GJ tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.

GJ-Tube

Insertion of a G-tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.

G-Tube

Jolie Ringash, MD

The purpose of this study is to compare the quality of life (QOL) in head and neck patients who are given the GJ tube (which is placed in the bowel) versus those who are given the G-Tube (which is placed in the stomach) for prophylactic feeding. The standard of care for patients at Princess Margaret Hospital (PMH) is using GJ tubes. Patients who agree to be in the study will be randomized to either the GJ-Tube or the G-Tube arm. Patients randomized to the G-tube will receive prophylactic intravenous and oral antibiotics prior to insertion of the G-tube. Antibiotics will be given for a total of 1 week. A few hours following tube insertion (on return to PMH ward), patients will complete a single item, visual analogue pain scale (VAS). Patients will remain in hospital for a minimum of 24 hours and until the patient and/or family is able to care for the Enteric Feeding(EF) device at home. Patients randomized to the GJ-Tube may receive i.v medication during the procedure. All Patients will be asked to fill out several questionnaires at different time- points of the study. All Patients will have regular assessments to evaluate their overall quality of Life, toxicity, and how they respond to treatment during the study. Patients will also be assessed after they completed study treatment.

Prophylactic enteral feeding tubes are used routinely for nutritional support during intensive radiotherapy or chemoradiotherapy for locally advanced head and neck cancer. Typically, tubes remain in place for up to 3-4 months. Whether small-bore jejunal (GJ) or larger bore gastric (G) tubes are used varies geographically, based on tradition, physician preference and availability of services. Feeding tube placement is arranged either prior to the start of RT, or more commonly within the first 2 weeks of RT, prior to the onset of severe mucositis. Patients are admitted to hospital for 1-3 days to monitor side effects of the procedure, and to allow our dietetic and nursing staff to provide intensive teaching on the use and care of the tube. Feeding tubes are kept in place through the treatment course and removed once patients are able to meet their calorie needs and maintain body weight through oral feeding. On average, feeding tubes are removed approximately 2-3 months after completion of RT; however, approximately 20% of patients may still require enteral feeding at 1 year post-treatment. This study will compare the QOL in patients who use the G tube versus the GJ tube.

Feeding Tube in Cancer Patients

A Randomized Comparison of Enteral Feeding for Head and Neck (HNC) Cancer Patients

A 20-item specific questionnaire scored using individual items from 1=not at all to 5=very much

A self-reported utility consisting of 20 discrete 5-level items rated from "strongly agree" to "strongly disagree"

weight will be measured at protocol-determined time points

•Quality of life as measured by Functional Assessment of Cancer Therapy-Head \& Neck (FACT-HN) ranking 24 individual items from 0= not at all to 4 = very much

Clinical toxicities will be grade according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4), a well known toxicity grading scale from 0 (asymptomatic) to 5 (death)

University Health Network, Toronto

Behaviors and Mental Disorders

Quality of Life

Micronutrients

Vitamins

Omega 3 Fatty Acid

This group of patients are to be given a tube feed enriched with 2.2 g Eicosapentaenoic Acid (EPA) per day for 5 days pre surgery and 21 days post surgery

This group are to be given a standard enteral tube feed without EPA for 5 days pre op and 21 days post surgery

This is an enteral tube feed with 125 kcals \& 6.65g protein per 100mls. It contains Fat, Carbohydrate, and vitamins and minerals and is enriched with 2.2g Eicosapentaenoic Acid per 500mls of feed. Patients on this trial who are randomized to Prosure will receive the product orally for 5 days prior to surgery and for 21 days post surgery vis a feeding jejunostomy tube

Prosure

This is a standard enteral tube feed with 150 kcals \& 6.3 g protein per 100mls as well as carbohydrate, fat and vitamins and minerals. It does not have any active immunonutrients. Patients randomized to this arm will receive the product for 5 days pre op and 21 days post surgery via a feeding jejunostomy tube

Ensure Plus

Aoife Ryan, PhD

John V Reynolds, MD

Laura A Healy

Laura A Healy, BSc RD

This study aims to examine whether providing tube feeding with a formula enriched with omega-3 fats is better than traditional standard tube feeding in terms of preserving nutritional status, improving immune function and reducing medical complications following major upper Gut cancer surgery.

Title A double blinded randomized controlled trial to investigate the effects of an enteral nutritional supplement enriched with Eicosapentaenoic acid on long term nutritional status post operatively specifically the maintenance of lean body mass, and its potential impact on quality of life as well as examining the stress response and immune function and in patients undergoing surgical treatment of esophageal cancer.

Investigational medicinal Product(s):

Prosure (Abbott Laboratories)

Comparator:

Ensure Plus (Abbott Laboratories)

Study Objectives To examine whether prolonged supplementation with a nutritional supplement enriched with Eicosapentaenoic acid is superior to standard nutritional products in terms of promoting anabolism and improving quality of life in patients undergoing surgical treatment of esophageal cancer.

Study Design - Prospective randomized controlled trial.

Primary Endpoints:

* Quality of life Scores using EORTC Questionnaires
* Nutritional status on day 21 post oesophagectomy and/or total gastrectomy(specifically lean body mass) and at out patient follow up

Secondary Endpoints:

* Effects on the immuno-inflammatory response to surgery
* Post operative Clinical outcome including SIRS, sepsis and organ failure

Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery

Randomized Double Blinded Trial to Investigate Effects of an Enteral Nutritional Supplement Enriched With Eicosapentaenoic Acid on Body Composition,Complications,Stress Response,Immune Function & Quality of Life in After Esophagectomy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Enteral Feeding in Discharged Patients	NCT02155140	Surgical Resect... Nutritional Sup...	Jejunal feeding	18 Years -	University Hospital Plymouth NHS Trust
Prevalence of Enteral Nutrition Interruption in an Oncology Intensive Care Unit.	NCT06156189	Critical Illnes...	Enteral Feeding	18 Years -	King Faisal Specialist Hospital and Research Centre Madinah
Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology	NCT04703985	Lymphoma Myeloma	Enteral Nutriti...	18 Years -	University Hospital, Bordeaux
Enteral Feeding in Discharged Patients	NCT02155140	Surgical Resect... Nutritional Sup...	Jejunal feeding	18 Years -	University Hospital Plymouth NHS Trust
Prevalence of Enteral Nutrition Interruption in an Oncology Intensive Care Unit.	NCT06156189	Critical Illnes...	Enteral Feeding	18 Years -	King Faisal Specialist Hospital and Research Centre Madinah
Design of the EFECTS Trial	NCT02017366	Esophageal Canc...	Enteral feeding	18 Years - 85 Years	University Hospital, Gasthuisberg
Feeding Tube in Cancer Patients	NCT02675673	Enteral Feeding...	GJ-Tube G-Tube	18 Years -	University Health Network, Toronto
Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery	NCT00790140	Esophageal Canc...	Prosure Ensure Plus	18 Years - 80 Years	University of Dublin, Trinity College
Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery	NCT00790140	Esophageal Canc...	Prosure Ensure Plus	18 Years - 80 Years	University of Dublin, Trinity College

Spots Global Cancer Trial Database for enteral feeding