Lymphocyte Enhancement in Gastroenteric Oncology

Fondazione IRCCS Policlinico San Matteo di Pavia54 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Advanced Gastrointestinal Cancers

Interventions

EAA supplementationDIETARY_SUPPLEMENT

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 placeboOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

RECRUITING

Outcomes

Primary Outcomes

Exit from lymphopenia

Proportion of patients exceeding the lymphopenia threshold level of 29.7%.

Time frame: 60 days

Secondary Outcomes

The change in the % of lymphocytes over time

Time frame: 0, 30, 60, 90 days

The proportion of patients with G3-G5 toxicity

Time frame: 60 days

The percentage of chemotherapy dose administered compared to that expected for the patients.

Time frame: 60 days

plasma aminoacids composition chang during treatment

The proportion of patients experiencing a ≥10% reduction in lactate, acetoacetate and a \>/= 10% increase in essential amino acids in plasma.

Time frame: 60 days

Data from ClinicalTrials.gov

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