Lymphocyte Enhancement in Gastroenteric Oncology

Advanced Gastrointestinal Cancers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343272
• Other study ID #: LEGO
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Fondazione IRCCS Policlinico San Matteo di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: February 28, 2025
• Est. primary completion date: December 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Gastrointestinal Cancers
• Gastrointestinal Neoplasms

Intervention

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

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Policlinico San Matteo di Pavia	University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exit from lymphopenia	Proportion of patients exceeding the lymphopenia threshold level of 29.7%.	60 days
Secondary	The change in the % of lymphocytes over time	The change in the % of lymphocytes over time	0, 30, 60, 90 days
Secondary	The proportion of patients with G3-G5 toxicity	The proportion of patients with G3-G5 toxicity	60 days
Secondary	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
Secondary	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