NCT02664974

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

2.2 years

First QC Date

January 13, 2016

Last Update Submit

January 26, 2016

Conditions

MalnutritionGastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Maintenance of body weight

    Evaluated by weight change after discharge

    2 months

Secondary Outcomes (2)

  • Improvement of quality of life

    2 months

  • Improvement of tolerance to chemotherapy

    6 months

Study Arms (2)

HEN group

EXPERIMENTAL

Home Enteral Nutrition

Dietary Supplement: Enteral nutrition

Control group

ACTIVE COMPARATOR

Dietary Counseling

Other: Dietary counseling

Interventions

Enteral nutritionDIETARY_SUPPLEMENT

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.

HEN group
Dietary counselingOTHER

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.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

European Institute of Oncology

Milan, Milan, 20100, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milan, 20133, Italy

Location

MeSH Terms

Conditions

MalnutritionGastrointestinal Neoplasms

Interventions

Enteral NutritionNutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Cecilia Gavazzi, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 27, 2016

Study Start

December 1, 2008

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

IT(2)