Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Study Overview
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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).

Official Title
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Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer: A Multicenter Randomized Clinical Trial

Conditions
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Malnutrition, Gastrointestinal Cancer

Intervention / Treatment
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* Dietary Supplement: Enteral nutrition
* Other: Dietary counseling


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEN group<br>Home Enteral Nutrition | Dietary Supplement: Enteral nutrition<br>* 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.<br>|
| Active Comparator: Control group<br>Dietary Counseling | Other: Dietary counseling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of body weight | Evaluated by weight change after discharge | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months | 
| Improvement of tolerance to chemotherapy | Evaluated by the ratio chemotherapy planned / chemotherapy administered | 6 months |