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

Sponsor
IRCCS San Raffaele
Study ID
NCT07590622
Status
Not Yet Recruiting

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Conditions

  • Gastrointestinal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
May 15, 2026
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

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. ]

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