Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase

Completed

Phase 3

Conditions

Malnutrition

Gastrointestinal Cancer

Treatments

Dietary Supplement: Enteral nutrition

Other: Dietary counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02664974

HEN

Details and patient eligibility

About

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).

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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