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

May 13, 2026 updated by: MARA PERSANO, IRCCS San Raffaele

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LH BLU
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
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.
Active Comparator: ONS
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2031

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAT-ING

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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