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Lymphocyte Enhancement in Gastroenteric Oncology | Clinical Trials | Clareo Health

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Lymphocyte Enhancement in Gastroenteric Oncology

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

NCT06343272•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.

Detailed Description

The aim of the study is to verify that, in lymphopenic patients, AAE supplementation leads to an increase in lymphocytes circulating in the blood. In particular, at the end of treatment, in patients with lymphocytes \< 29.7% of the total number of white blood cells, we want to observe the disappearance of lymphopenia.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•diagnosis of epithelial neoplasia of the gastrointestinal tract in advanced stage with indication for first-line chemotherapy for palliative purposes and with circulating lymphocytes \< 29.7% of the number total white blood cells in the blood.
•ECOG PS ≤ 2
•start of first-line palliative chemotherapy agreement with AIOM guidelines.
•adequate nutritional counseling carried out before starting of the treatment
•willing to participate by providing written informed consent

Exclusion Criteria

•age \< 18 years
•current or indicated artificial nutrition
•gluten intolerance
•prediction of use of granulocyte growth factors
•confirmed diagnosis of COPD, chronic heart failure, insufficiency chronic kidney disease, chronic liver failure, collagen disease, diseases endocrine, insulin-dependent diabetes, malignancy in other locations. All these conditions are associated with documented alterations in the plasma profile of amino acids and potentially of subsets of circulating T lymphocytes.

Locations (1)

IRCCS Policlinico San Matteo

Pavia, Italy

Key Dates

Start Date

March 22, 2022

Primary Completion Date

December 22, 2024

Completion Date

February 28, 2025

Last Updated

April 3, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Gastrointestinal Cancers

Interventions

EAA supplementation

DIETARY_SUPPLEMENT

Isocaloric placebo

OTHER