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

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.

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.
Availability to take ONS.
Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.
An ECOG PS of 2 or less.
Investigator's assessment of life expectancy ≥ 3 months.

Exclusion criteria

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;
Pregnancy or lactation.

Treatment and study plan

LH BLU

Dietary Supplement

LH 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 Supplement

Patients 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.

Primary outcomes

Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.

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.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: EAT-ING

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2031
First posted: May 15, 2026
Registry last updated: May 15, 2026

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.

Published trials that share one or more normalized conditions with this study.

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