Neoplasms

Digestive System Diseases

All Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Esophageal Neoplasms

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Nutrition Disorders

Esophageal Cancer

The study group will receive the dietary supplement preoperatively and for three months after the operation

prosure

Athina-Despina Kimpizi

Athina-Despoina Kimpizi

Dimitrios Theodorou

Upper GI malignancies often lead to involuntary weight loss and nutritional deficits. Nutritional support, both pre- and postoperatively, may improve post-operative course and reduce length of hospital stay. This prospective randomized trial aims to investigate the above mentioned hypothesis and clarify any variants that may differ between the investigation and control group at a statistically significant level.

This prospective randomized trial is conducted in the 1st Propaedeutic Department of Surgery of National and Kapodistrian University of Athens. The study population consists of adults suffering from upper GI malignancy. Informed consent is obtained in written. Following this, the patient is classified in either the intervention group or the control group. Patients belonging in the control group will receive the usual postoperative care, while the patients in the intervention group will receive nutritional support perioperatively. The aforementioned "usual postoperative care" consists of administration of intravenous fluids until resuming oral feeding, jejunostomy feeding starting from the first postoperative day, epidural analgesics for the first four postoperative days, perioperative administration of a second generation cephalosporin plus metronidazole and thromboprophylaxis with (low moleculr weight heparin (LMWH). The patients are also receiving appropriate for any concomitant health problems (e.g. existing diabetes mellitus) and transfusions based on their needs. We record the patient's age, the stage and histologic type of the disease, administration of adjuvant and/or neoadjuvant therapy and the patient's American Society of Anesthesiologists Score. Their preoperative nutritional state will be assessed using Body Mass Index (BMI), serum albumin, body fat percentage, muscle mass and total body water following measurement with body composition analyzer (Tanita MC-780U Multi Frequency Segmental Body Composition Analyzer). At their initial assessment the patients will fill in an appropriate quality of life questionnaire. The type of the operation, the use of drains and catheters, the patients needs in iv fluids, blood product transfusions, sedatives and analgesics during the operation will also be recorded. The postoperative course of any patient will be closely monitored, including the postoperative needs in fluid administration and analgesics, the need for transfusion, the administration of perioperative antibiotics, the removal of drains and catheters, the time of first bowel movement,the need of ICU hospitalization, the total length of hospital stay as well as any in-hospital complications. Upon discharge from the hospital, the control group will receive instructions on oral and jejunostomy feeding, while the intervention group will receive additional nutritional support for 3 months. Both patient groups will undergo post-operative follow-up for six months. In the first, third and sixth postoperative month body weight and its change, BMI, serum albumin, body fat percentage, muscle mass and total body water, as well as quality of life, postoperative complications and need for readmission will be evaluated. Neoadjuvant therapy will also be taken into account. The results will be statistically evaluated after appropriate stratification.

Perioperative Nutritional Support in Esophageal Cancer Patients

surgical site infection,pneumonia,intraabdominal sepsis,postoperative fever or other signs of sepsis

anastomotic leak confirmed either by a CT scan or upper gastrointestinal series

cardiac complications confirmed by ECG that required consultation by a cardiologist

need for reoperation due to postoperative complications in the first six postoperative months

death related to the known malignancy,including postoperative complications

THEODOROU DIMITRIOS

PROFESSOR

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Weight Loss

Body Weight

Body Weight Changes

Thinness

Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care

Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme

Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition

ProSure

Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week

Physical Exercise

In patients with incurable cancer, general deterioration in their ability to walk, exercise and care for themselves is often regarded as an inevitable consequence of this. In 2015, Hospice UK published a report advocating "Rehabilitative Palliative Care".

However there is limited robust evidence on which to base this approach. Reviews of the literature show limited study numbers but do suggest that rehabilitation may be feasible for advanced cancer patients. However key components were not clear and no recommendations could be given.

This trial is designed primarily to test the feasibility of a rehabilitation programme (exercise and nutritional supplementation) in advanced cancer patients. Feasibility will be the primary outcome measure including rates of recruitment and compliance. Secondary outcome measures include impact on physical function, nutritional status, quality of life for patients and their carers. We will also assess the health economic impact by assessing patient health facility use throughout the trial.

40 patients with advanced cancer living in the community will be recruited from two hospice palliative care teams in Edinburgh. These patients will be randomised in to either the treatment arm: the rehabilitation programme plus standard care, or the control arm: standard care alone. The treatment arm will consist of an 8 week rehabilitation programme, supervised at weekly clinics by a physiotherapist and dietician.

To minimise contamination the control group will be offered the treatment at the end of the 8 weeks (waiting list control).

Measurements will be made for both groups and compared at baseline (week 0), midpoint (week 5) and endpoint (week 9). Recommendations for a larger UK wide trial will be made from the findings of this study.

Randomised (1:1) unblinded feasibility trial of a rehabilitation programme (exercise and nutrition) versus waiting list control, in patients with advanced cancer

Exercise and Nutritional Rehabilitation in Patients With Cancer

Exercise and Nutritional Rehabilitation in Patients With Cancer, Randomised (1:1) Unblinded Feasibility Trial of a Rehabilitation Programme (Exercise and Nutrition) Versus Waiting List Control, in Patients With Advanced Cancer

Compliance with treatment and trial procedures

Measured by EORTC QLQ-C15-PAL questionnaire

Mean daily step count, measured by Physical Activity Meter over 5 days

Measured by two-minute walk test (metres/feet covered)

Measured by Karnofsky performance status (KPS) at baseline, mid and endpoint

Measured by timed up-and-go test (Seconds)

Measured by physical activity meter at baseline and endpoint (Mean sleep hours, mean hours restless and hours awake)

Height and weight measured at baseline, mid and endpoint assessment (m, Kg and combined as kg/m2)

Measured by PG-SGA nutritional assessment (PG-SGA point score)

Measured by dietary intake using 24 hour recall (patient diary entries)

Measured by change in measures of physical function (see outcomes 4-8) in control group from baseline measurement to endpoint

Marie Curie Hospice, Belfast

Accord Clinical Research

NHS Lothian

University of Edinburgh

Behaviors and Mental Disorders

Quality of Life

Micronutrients

All Drugs and Chemicals

Other Dietary Supplements

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
Perioperative Nutritional Support in Esophageal Cancer Patients	NCT04190121	Esophageal Canc... Nutritional Def...	prosure	18 Years -	University of Athens
Exercise and Nutritional Rehabilitation in Patients With Cancer	NCT03316157	Cachexia; Cance... Diet Modificati... Physical Activi... Advanced Cancer	ProSure Physical Exerci...	18 Years -	University of Edinburgh
Exercise and Nutritional Rehabilitation in Patients With Cancer	NCT03316157	Cachexia; Cance... Diet Modificati... Physical Activi... Advanced Cancer	ProSure Physical Exerci...	18 Years -	University of Edinburgh
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 prosure

Every month we try and update this database with for prosure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prosure

Every month we try and update this database with for prosure cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prosure cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.