Perioperative Nutritional Support in Esophageal Cancer Patients (NEEC)

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer; Nutritional Deficiency
• Intervention / Treatment: Dietary supplement: prosure

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Recruiting
    • Hippocration Hospital
    • Contact: Athina-Despoina Kimpizi; Phone Number: +302132088142; Email: despinakimpizi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with esophageal cancer
• 18 years or older

Exclusion Criteria:

-none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP A	Dietary supplement: prosure; The study group will receive the dietary supplement preoperatively and for three months after the operation
No Intervention: GROUP B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infective complications	surgical site infection,pneumonia,intraabdominal sepsis,postoperative fever or other signs of sepsis	first six postoperative months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anastomotic leak	anastomotic leak confirmed either by a CT scan or upper gastrointestinal series	first six postoperative months
postoperative arrhythmia or other cardiac complications	cardiac complications confirmed by ECG that required consultation by a cardiologist	first six postoperative months
readmission rate		first six postoperative months
reoperation	need for reoperation due to postoperative complications in the first six postoperative months	first six postoperative months
disease-associated death during the first six postoperative months	death related to the known malignancy,including postoperative complications	first six postoperative months
length of hospital stay	postoperative duration of hospital stay	first six postoperative months (including first admission and any other readmission)
length of stay in the ICU		first six postoperative months

Other Outcome Measures

Outcome Measure	Time Frame
patient's BMI changes	first six postoperative months
patient's muscle mass changes	first six postoperative months
patient's body fat changes	first six postoperative months
patient's serum albumin changes	first six postoperative months

Collaborators and Investigators

• Sponsor: THEODOROU DIMITRIOS
• Investigators: Study Chair: Dimitrios Theodorou, Hippocration Hospital; Principal Investigator: Athina-Despina Kimpizi, Hippocration Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Anticipated): February 14, 2022
• Study Completion (Anticipated): February 14, 2022

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: esophageal cancer,nutritional support
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Nutrition Disorders; Head and Neck Neoplasms; Esophageal Diseases; Malnutrition; Esophageal Neoplasms
• Other Study ID Numbers: 17771

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No