EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers

EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers: A Single-Center Randomized Trial

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.

The aim of the present project is to evaluate, with a randomized open-label study, the effect of providing nutritional counselling combined with a high-protein and high-calorie ONS enriched with immunonutrients named LH BLU in reducing serious AEs rate in patients with advanced GI cancers undergoing first-line treatment.

Inclusion Criteria:

1. Will to participate by providing written IC.
2. Male or female aged 18 years or older.
3. A confirmed histological or radiological (in case of hepatocellular carcinoma) diagnosis of advanced GI cancer.
4. Undergoing first-line systemic treatment for advanced disease as determined by the investigators, following good clinical practice and guidelines.
5. Availability to take ONS.
6. Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.
7. An ECOG PS of 2 or less.
8. Investigator's assessment of life expectancy ≥ 3 months.

Exclusion Criteria:

1. Are under 18 years of age.
2. Inability to sign an IC.
3. Inability to follow the procedures of the study, e.g. due to language barrier, major psychological disorders, dementia, etc.;
4. Indication to ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS;
5. Pregnancy or lactation.