Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

January 26, 2016 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy, 20100
        • European Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEN group
Home Enteral Nutrition
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.
Active Comparator: Control group
Dietary Counseling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of body weight
Time Frame: 2 months
Evaluated by weight change after discharge
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of quality of life
Time Frame: 2 months
Evaluated at hospital admission and two months after discharge by the self-administrated Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
2 months
Improvement of tolerance to chemotherapy
Time Frame: 6 months
Evaluated by the ratio chemotherapy planned / chemotherapy administered
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: Cecilia Gavazzi, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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