NCT05852990 Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
| NCT ID | NCT05852990 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Instituto Nacional de Cancerologia de Mexico |
| Condition | Non-Small Cell Lung Cancer With EGFR Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 28 participants in total. It began in 2022-03-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * Patients who cannot attend the first protocol appointment. * Treatment with other anti-cancer therapy * Participating in other clinical trials in the former four weeks * 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. * Breastfeeding.
Contact & Investigator
Oscar G Arrieta Rodriguez, M.D., M.Sc.
PRINCIPAL INVESTIGATOR
Instituto Nacional de Cancerología de México
Frequently Asked Questions
Who can join the NCT05852990 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Non-Small Cell Lung Cancer With EGFR Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05852990 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 28 participants.
Is NCT05852990 currently recruiting?
Yes, NCT05852990 is actively recruiting participants. Contact the research team at ogar@unam.mx for enrollment information.
Where is the NCT05852990 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT05852990 clinical trial?
NCT05852990 is sponsored by Instituto Nacional de Cancerologia de Mexico. The principal investigator is Oscar G Arrieta Rodriguez, M.D., M.Sc. at Instituto Nacional de Cancerología de México. The trial plans to enroll 28 participants.
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