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| Name | Class |
|---|---|
| University of Pavia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sperimental | Experimental |
| |
| Isocaloric placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EAA supplementation | Dietary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exit from lymphopenia | Proportion of patients exceeding the lymphopenia threshold level of 29.7%. | 60 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
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| Isocaloric placebo | Other | 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 |
|
| 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 |