Gastrointestinal Cancer, Malnutrition
Conditions
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTEnteral 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 Home Enteral Nutrition can be withdrawn in the treated group, after 2 months from discharge, whenever a weight gain ≥ 5% is reported, and oral alimentation is regular and adequate.
OTHERDietary 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.
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of body weight | 2 months | Evaluated by weight change after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of quality of life | 2 months | Evaluated at hospital admission and two months after discharge by the self-administrated Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire |
| Improvement of tolerance to chemotherapy | 6 months | Evaluated by the ratio chemotherapy planned / chemotherapy administered |
Countries
Italy
Outcome results
None listed