Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer

Last updated: January 26, 2016
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Overall Status: Completed

Phase

3

Condition

Gastric Cancer

Colon Cancer; Rectal Cancer

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT02664974
HEN
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 homeartificial nutrition

Study Design

Total Participants: 79
Study Start date:
December 01, 2008
Estimated Completion Date:
June 30, 2011

Connect with a study center

  • European Institute of Oncology

    Milan, 20100
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133
    Italy

    Site Not Available

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