Enhancing lymphocyte levels in patients with advanced gastrointestinal cancers
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
This study is testing if giving essential amino acids can help increase immune cell levels and improve chemotherapy tolerance in patients with advanced gastrointestinal cancers who have low lymphocyte counts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06343272 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of essential amino acid (EAA) supplementation on lymphocyte counts and chemotherapy tolerance in patients with advanced gastrointestinal cancers who are not candidates for immune checkpoint inhibitors. It is a single-center, double-blind, randomized trial focusing on patients with low lymphocyte levels. The study aims to determine if EAA supplementation can effectively increase circulating lymphocytes and alleviate lymphopenia in these patients. Participants will receive either EAA supplementation or an isocaloric placebo during their first-line palliative chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced epithelial neoplasia of the gastrointestinal tract, low lymphocyte counts, and who are starting first-line palliative chemotherapy.
Not a fit: Patients under 18 years old, those requiring artificial nutrition, or with certain chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve immune function and treatment tolerance in patients with advanced gastrointestinal cancers.
How similar studies have performed: While the approach of using EAA supplementation is promising, it is not widely tested in this specific context, making this study relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pavia
- IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.