Clinical trial · Interventional
Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer
Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer: A Multicenter Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary counseling | Other | — | UNRESOLVED |
| Enteral nutrition | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HEN group
- description
- Home Enteral Nutrition
- interventionNames
- Dietary Supplement: Enteral nutrition
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Dietary Counseling
- interventionNames
- Other: Dietary counseling
Primary outcomes (1)
- measure
- Maintenance of body weight
- timeFrame
- 2 months
- description
- Evaluated by weight change after discharge
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available