Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664974
• Other study ID #: HEN
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2016
• Last updated: January 26, 2016
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: January 2016
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Malnutrition

Intervention

Dietary Supplement:
• Enteral 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.

Other:
• Dietary 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.

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of body weight	Evaluated by weight change after discharge	2 months	No
Secondary	Improvement of quality of life	Evaluated at hospital admission and two months after discharge by the self-administrated Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire	2 months	No
Secondary	Improvement of tolerance to chemotherapy	Evaluated by the ratio chemotherapy planned / chemotherapy administered	6 months	No