Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Phase 3

Completed

• Conditions: Malnutrition; Gastrointestinal Cancer
• Interventions: Other: Dietary counseling; Dietary Supplement: Enteral nutrition

• Registration Number: NCT02664974
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2011-02
• Study Completion: 2011-06
• Status Verified: 2016-01
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Study First Posted: 2016-01-27
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Dietary counseling	Dietary Counseling
HEN group	Enteral nutrition	Home Enteral Nutrition

Primary Outcome Measures

Name	Time	Method
Maintenance of body weight	2 months	Evaluated by weight change after discharge

Secondary Outcome Measures

Name	Time	Method
Improvement of tolerance to chemotherapy	6 months	Evaluated by the ratio chemotherapy planned / chemotherapy administered
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

Trial Locations

Locations (2)

European Institute of Oncology; 🇮🇹 Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy