The use of immunomodulants in patients with GI cancer has been progressively gaining attention in the last years, as a high-calorie-high-protein nutritional blend enriched in immunonutrients has shown efficacy in several studies in reducing the risk of post-operative complications and the length of stay of patients undergoing major cancer surgery.
The guidelines for the nutritional management of patients with cancer agree on the utility of nutritional support, whenever it is necessary, to improve clinical outcomes, and the efficacy and tolerability of treatments.
To our knowledge, this is among the first clinical trial specifically designed to evaluate the role of immunomodulants-enriched ONS in combination with nutritional counseling in reducing serious AEs rate in patients with advanced GI cancers undergoing systemic treatments.
Will to participate by providing written IC.
Male or female aged 18 years or older.
A confirmed histological or radiological (in case of hepatocellular carcinoma) diagnosis of advanced GI cancer.
Undergoing first-line systemic treatment for advanced disease as determined by the investigators, following good clinical practice and guidelines.
Are under 18 years of age.
Inability to sign an IC.
Inability to follow the procedures of the study, e.g. due to language barrier, major psychological disorders, dementia, etc.;
Indication to ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS;
Parallel
LH BLU
Dietary supplementLH BLU is a FSMP containing fats, carbohydrates, proteins and soluble fibers. In addition, LH BLU contains L-Glutamine, carnosine, vitamin D3, zinc, selenium, fructooligosaccharide, inulin and botanical extracts.
ONS
Dietary supplementPatients of control group will receive nutritional counseling consisting of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences in order to achieve estimated protein-calorie requirements and taking into account chewing and swallowing abilities.
Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs.
Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs, as defined by the Common Terminology Criteria for Adverse Events, version 5.0.
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This trial is not recruiting at the moment. You can still explore other options:
