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

Launched by INSTITUTO NACIONAL DE CANCEROLOGIA DE MEXICO · May 2, 2023

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ClinConnect Summary

**Summary of the Clinical Trial: Glutamine Plus L. Reuteri for Diarrhea Prevention in Lung Cancer Patients**

This clinical trial is looking at whether adding glutamine and a probiotic called Lactobacillus reuteri to a special diet can help prevent diarrhea in patients with advanced non-small cell lung cancer (NSCLC) who are receiving a type of treatment known as tyrosine kinase inhibitors (TKIs). Diarrhea is a common side effect of TKIs, and the researchers want to see if this combination can make a difference. Participants in the study will follow a specific diet that includes 10 grams of glutamine and 100 million CFU (colony-forming units) of L. reuteri, and they will be compared to others on a standard diet without these supplements.

To join the study, patients must be at least 18 years old, have a confirmed diagnosis of NSCLC that is at least stage IIIB, and be scheduled to receive TKI treatment. They should also be in reasonably good health, with a life expectancy of more than eight weeks. However, those with serious health issues, active infections, or certain other conditions may not be eligible. Participants will need to provide consent to take part in the study and will be closely monitored throughout the trial. This research could potentially lead to better management of a common side effect of cancer treatment, making the experience easier for patients.

Gender

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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.