Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstituto Nacional de Cancerologia de Mexico
About this trial
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
Qualifiers
Both sexes
≥ 18 years old
Pathologically confirmed diagnosis of NSCLC
Stage IIIB - IV by the American Joint Committee of Cancer Version 8.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Glutamine plus L. reuteri
Treatment groups
28 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov