Advanced Gastrointestinal Cancers
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTEAA 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
OTHERIsocaloric 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
Sponsors
University of Pavia
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exit from lymphopenia | 60 days | Proportion of patients exceeding the lymphopenia threshold level of 29.7%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in the % of lymphocytes over time | 0, 30, 60, 90 days | The change in the % of lymphocytes over time |
| The proportion of patients with G3-G5 toxicity | 60 days | The proportion of patients with G3-G5 toxicity |
| The percentage of chemotherapy dose administered compared to that expected for the patients. | 60 days | The percentage of chemotherapy dose administered compared to that expected for the patients. |
| plasma aminoacids composition chang during treatment | 60 days | The proportion of patients experiencing a ≥10% reduction in lactate, acetoacetate and a \>/= 10% increase in essential amino acids in plasma. |
Countries
Italy
Outcome results
None listed