RecruitingPhase 3NCT05852990

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

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

Sponsor

Instituto Nacional de Cancerologia de Mexico

Enrollment

28 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Non-Small Cell Lung Cancer With EGFR Mutation

Summary

This open-label randomized clinical trial aims to evaluate the glutamine plus Lactobacillus reuteri supplementation effect in a standard-of-care diet in EGFR mutant patients with advanced non-small cell lung cancer (NSCLC) under tyrosine kinase inhibitors (TKIs) therapy. The main question it aims to answer is ¿What is the effect of glutamine plus L. reuteri added to an astringent diet in preventing diarrhea generated by TKI therapy? Patients will receive an astringent diet supplemented with 10 grams of glutamine and L. reuteri (100 million CFU). Researchers will compare the Glutamine plus L. reuteri diet with a standard astringent diet to see if TKI therapy diarrhea is prevented.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking glutamine (an amino acid supplement) combined with a probiotic called L. Reuteri can prevent or reduce diarrhea caused by EGFR-targeted therapy (a type of oral cancer drug) in people with non-small cell lung cancer (NSCLC). **You may be eligible if...** - You are 18 or older - You have been diagnosed with non-small cell lung cancer (NSCLC), stage IIIB or IV - You are scheduled to receive an EGFR-targeting drug (1st or 2nd generation TKI) - You are in reasonably good health (ECOG score 2 or less) with a life expectancy of more than 8 weeks **You may NOT be eligible if...** - You are receiving other anti-cancer therapies at the same time - You participated in another clinical trial in the past 4 weeks - You have an active HIV infection, active hepatitis, or a serious uncontrolled condition - You are breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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