Gastrointestinal Cancer
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTLH 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.
DIETARY_SUPPLEMENTONS
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.
Sponsors
IRCCS San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs. | 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. |
Outcome results
None listed