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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| 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. |
|
| D005767 |
| Gastrointestinal Diseases |