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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Gastrointestinal Cancers
• Intervention / Treatment: Dietary supplement: EAA supplementation; Other: Isocaloric placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • IRCCS Policlinico San Matteo
    • Contact: Alessandra Ferrari; Phone Number: +39 0382.503689; Email: alessandra.ferrari@smatteo.pv.it
    • Principal Investigator: Salvatore Corallo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sperimental	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
Placebo Comparator: Isocaloric placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exit from lymphopenia	Proportion of patients exceeding the lymphopenia threshold level of 29.7%.	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the % of lymphocytes over time	The change in the % of lymphocytes over time	0, 30, 60, 90 days
The proportion of patients with G3-G5 toxicity	The proportion of patients with G3-G5 toxicity	60 days
The percentage of chemotherapy dose administered compared to that expected for the patients.	The percentage of chemotherapy dose administered compared to that expected for the patients.	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.	60 days

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Collaborators: University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Estimated): December 22, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: LEGO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No