Lymphocyte Enhancement in Gastroenteric Oncology

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial, called LEGO, is looking at how adding an essential amino acid (EAA) supplement might help people with advanced gastrointestinal cancers who are receiving chemotherapy. The goal is to see if this supplement can increase the number of certain immune cells in the blood, called lymphocytes, and improve how well patients tolerate their chemotherapy treatments. This study is being conducted at one center and is currently recruiting participants.

To be eligible for the trial, participants should be between the ages of 65 and 74, have a specific type of advanced cancer in the gastrointestinal tract, and have low lymphocyte levels in their blood. They should also be planning to start first-line chemotherapy for palliative care, which means treatment aimed at relieving symptoms rather than curing the disease. Participants will need to provide written consent and have a proper nutritional assessment before starting the treatment. It's important to note that those under 18, with certain health conditions, or who require special nutritional support would not qualify for this trial. If you choose to participate, you can expect to help researchers learn more about how EAA supplementation might support cancer treatment and improve patient care.

Gender

ALL

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.