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Lymphocyte Enhancement in Gastroenteric Oncology
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
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
Conditions
Interventions
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
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