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RECRUITING
NCT06343272
NA

Lymphocyte Enhancement in Gastroenteric Oncology

Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

View on ClinicalTrials.gov

Summary

LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens.

Official title: Effects of a Supplementation With a Mixture of Essential Amino Acids on Enhancing the Number of Circulating Lymphocytes and Improveing the Tolerance to Chemotherapy Treatment in Patients With Advanced Gastroinmtestinal Malignances the LEGO Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2022-03-22

Completion Date

2025-02-28

Last Updated

2024-04-03

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

EAA supplementation

The experimental group will receive the mixture (Amino-Ther® PRO, Professional Dietetics, Milan) composed of (in mg): L-leucine 1200, l L-isine 900, L-threonine 700, L-isoleucine 600, L-valine 600, L-cystine 150, L histidine 150, L-phenylalanine 100, L-methionine 50, L-tryptophan 50, vitamin B6 0.85, vitamin B1 0.70, citric acid 409, acidomalic 102.5, succinic acid 102.5. 1 sachet dissolved in 150 ml of water at 10.00 am +1 sachet at 4.00 pm daily for 60 days There are: proteins 0.00 g, carbohydrates 2.1 g, fats 0.00 g

OTHER

Isocaloric placebo

The control group will take 25g of maltodextrins daily with the same methods as the treated group: 1 sachet dissolved in 150 ml of water at 10.00 am +1 sachet at 4.00 pm daily for 60 days

Locations (1)

IRCCS Policlinico San Matteo

Pavia, Italy