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Trial Title:
Lymphocyte Enhancement in Gastroenteric Oncology
NCT ID:
NCT06343272
Condition:
Advanced Gastrointestinal Cancers
Conditions: Official terms:
Gastrointestinal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
EAA supplementation
Description:
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
Arm group label:
Sperimental
Intervention type:
Other
Intervention name:
Isocaloric placebo
Description:
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
Arm group label:
Isocaloric placebo
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessandra Ferrari
Phone:
0382.503689
Phone ext:
+39
Email:
alessandra.ferrari@smatteo.pv.it
Investigator:
Last name:
Salvatore Corallo
Email:
Principal Investigator
Start date:
March 22, 2022
Completion date:
February 28, 2025
Lead sponsor:
Agency:
Fondazione IRCCS Policlinico San Matteo di Pavia
Agency class:
Other
Collaborator:
Agency:
University of Pavia
Agency class:
Other
Source:
Fondazione IRCCS Policlinico San Matteo di Pavia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06343272
