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OpenTrials
Completed

NCT Number: NCT02664974

Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

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).

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Key information

Conditions

Malnutrition Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

European Institute of Oncology, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Nutrition

Dietary 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Home Enteral Nutrition can be withdrawn in the treated group, after 2 months from discharge, whenever a weight gain ≥ 5% is reported, and oral alimentation is regular and adequate.

Dietary Counseling

Other

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 outcomes

  1. Maintenance of body weight

    Time frame: 2 months

    Evaluated by weight change after discharge

Secondary outcomes

  1. 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. Improvement of tolerance to chemotherapy

    Time frame: 6 months

    Evaluated by the ratio chemotherapy planned / chemotherapy administered

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2016
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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