Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer

What this Trial Is About

This research aims to evaluate the effect of adding glutamine plus Lactobacillus reuteri to an astringent diet in patients with advanced non-small cell lung cancer (NSCLC) who have EGFR mutations and are receiving tyrosine kinase inhibitor (TKI) therapy. The main question is whether this supplemented diet can help prevent diarrhea caused by TKI treatment. This is an open-label randomized clinical trial sponsored by the Instituto Nacional de Cancerologia de Mexico. Participants in the experimental group will receive an astringent diet supplemented with two sachets daily, each containing 10 grams of glutamine and 100 million colony forming units of Lactobacillus reuteri, for up to six weeks or until death. The control group will follow a standard astringent diet without supplementation. All patients will receive nutritional counseling every two weeks during the study. Throughout the trial, researchers will monitor diarrhea toxicity and assess quality of life using chronic illness therapy tools and lung cancer-specific questionnaires every two weeks from the first dose of TKI therapy up to six weeks. Gastrointestinal toxicity grades and health-related quality of life measures will also be recorded. The study period includes regular evaluations to understand the effects of the diet supplement on TKI-related diarrhea and patient well-being.

Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC