Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
Key facts
- Where
- Mexico City, MexicoSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05852990, who can take part
Where in Mexico
- Instituto Nacional De Cancerologia de MexicoMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto Nacional de Cancerologia de Mexico
- Trial code
- NCT05852990
- Record updated
- 9 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Both sexes; ≥ 18 years old; Pathologically confirmed diagnosis of NSCLC; Stage IIIB - IV by the American Joint Committee of Cancer Version 8; Candidates to receive EGFR-TKI treatment (1st \& 2nd generation TKI); ECOG score ≤ 2; Life expectancy > eight weeks; Signed written informed consent.
Exclusion: Treatment with other anti-cancer therapy; Any other serious condition or uncontrolled active infection, altered mental status or psychiatric disorder that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results; Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel; Active HIV infection; Patients who cannot attend the first protocol appointment; Participating in other clinical trials in the former four weeks; Breastfeeding.