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

NCT07590622 | Not Yet Recruiting DMC

• 1 other identifier: EAT-ING
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

LH BLU

EXPERIMENTAL

Patients of interventional group will receive the immunomodulant LH BLU and 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.

Dietary Supplement: LH BLU

ONS

ACTIVE COMPARATOR

Patients of interventional 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.

Dietary Supplement: ONS

Interventions

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.

LH BLU

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.

ONS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: May 15, 2026

Record last verified: 2026-04