Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastrointestinal Cancers | Malignant Digestive System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EAA supplementation | Dietary Supplement | — | UNRESOLVED |
| Isocaloric placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sperimental
- interventionNames
- Dietary Supplement: EAA supplementation
- type
- PLACEBO_COMPARATOR
- label
- Isocaloric placebo
- interventionNames
- Other: Isocaloric placebo
Primary outcomes (1)
- measure
- Exit from lymphopenia
- timeFrame
- 60 days
- description
- Proportion of patients exceeding the lymphopenia threshold level of 29.7%.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available