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Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Primary Purpose

Malnutrition, Gastrointestinal Cancer

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Enteral nutrition
Dietary counseling
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • European Institute of Oncology
  • Fondazione IRCCS Istituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HEN group

Control group

Arm Description

Home Enteral Nutrition

Dietary Counseling

Outcomes

Primary Outcome Measures

Maintenance of body weight
Evaluated by weight change after discharge

Secondary Outcome Measures

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
Improvement of tolerance to chemotherapy
Evaluated by the ratio chemotherapy planned / chemotherapy administered

Full Information

First Posted
January 13, 2016
Last Updated
January 26, 2016
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT02664974
Brief Title
Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer
Official Title
Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer: A Multicenter Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Gastrointestinal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEN group
Arm Type
Experimental
Arm Description
Home Enteral Nutrition
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Dietary Counseling
Intervention Type
Dietary Supplement
Intervention Name(s)
Enteral nutrition
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maintenance of body weight
Description
Evaluated by weight change after discharge
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Improvement of quality of life
Description
Evaluated at hospital admission and two months after discharge by the self-administrated Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire
Time Frame
2 months
Title
Improvement of tolerance to chemotherapy
Description
Evaluated by the ratio chemotherapy planned / chemotherapy administered
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Gavazzi, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20100
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

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Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

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