Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano79 enrolled

Overview

Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial. The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Malnutrition Gastrointestinal Cancer

Interventions

Home Enteral Nutrition was planned to cover the basal energy requirement calculated with Harris Benedict Formula, it was administrated preferentially during nocturnal hours as an integration of oral diet. Enteral Nutrition included any standard polymeric formula providing 1-1.5 Kcal/mL with carbohydrates 50%-60%, lipids 25%-35% and protein 12%-20%. Home Enteral Nutrition can be withdrawn in the treated group, after 2 months from discharge, whenever a weight gain ≥ 5% is reported, and oral alimentation is regular and adequate.

Dietary counselingOTHER

Specific nutritional advices including total energy and protein requirements were provided to patients and oral high-calorie supplements were prescribed whenever necessary. Home Enteral Nutrition can be started in patients of the control group, not before two months from discharge, if a further weight loss ≥ than 5% is reported.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Both gender with age higher than 18 years. * Documented cancer of the gastrointestinal tract: oesophagus, stomach, pancreas, biliary tract * Candidate for major elective surgery. * Preoperative nutritional risk score ≥ 3 * Written informed consent. Exclusion Criteria: * Age \< 18 years * Karnofsky index \< 60 * Renal insufficiency (Ongoing haemodialysis or plasma creatinine \> 3 mg/dL) * Respiratory insufficiency * Child-Pugh class C * Short Bowel Syndrome * Pregnancy * Emergency operation * Foreign residence or residence in Italian region with no regulation designed for home artificial nutrition

Locations (2)

European Institute of Oncology

Milan, Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milan, Italy

Outcomes

Primary Outcomes

Maintenance of body weight

Evaluated by weight change after discharge

Time frame: 2 months

Secondary Outcomes

Improvement of quality of life

Evaluated at hospital admission and two months after discharge by the self-administrated Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire

Time frame: 2 months

Improvement of tolerance to chemotherapy

Evaluated by the ratio chemotherapy planned / chemotherapy administered

Time frame: 6 months