Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

F

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase

Completed
Phase 3

Conditions

Malnutrition
Gastrointestinal Cancer

Treatments

Dietary Supplement: Enteral nutrition
Other: Dietary counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02664974
HEN

Details and patient eligibility

About

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).

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

79 participants in 2 patient groups

HEN group
Experimental group
Description:
Home Enteral Nutrition
Treatment:
Dietary Supplement: Enteral nutrition
Control group
Active Comparator group
Description:
Dietary Counseling
Treatment:
Other: Dietary counseling

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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