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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • LH BLU
  • ONS

Treatment groups

88 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators