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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 ID: 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
European Institute of Oncology, Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
Name: Cecilia Gavazzi, MD
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Role: PRINCIPAL_INVESTIGATOR