Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

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

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).

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