Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Malnutrition Gastrointestinal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HEN group

Home Enteral Nutrition

Group Type EXPERIMENTAL

Enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

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Home Enteral Nutrition can be withdrawn in the treated group, after 2 months from discharge, whenever a weight gain ≥ 5% is reported, and oral alimentation is regular and adequate.

Control group

Dietary Counseling

Group Type ACTIVE_COMPARATOR

Dietary counseling

Intervention Type OTHER

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.

Interventions

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Enteral nutrition

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.

Intervention Type DIETARY_SUPPLEMENT

Dietary counseling

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No