Glutamine and L. Reuteri to prevent diarrhea in lung cancer patients on TKI therapy
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 study is testing if adding glutamine and a probiotic called L. reuteri to the diet can help prevent diarrhea in lung cancer patients receiving TKI treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Cancerologia de Mexico Academic / other |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT05852990 on ClinicalTrials.gov |
What this trial studies
This open-label randomized clinical trial evaluates the effects of glutamine and Lactobacillus reuteri supplementation in patients with advanced non-small cell lung cancer (NSCLC) who are undergoing treatment with tyrosine kinase inhibitors (TKIs). Participants will receive a standard astringent diet supplemented with 10 grams of glutamine and 100 million CFU of L. reuteri, while a control group will receive only the standard diet. The study aims to determine if this supplementation can effectively prevent diarrhea associated with TKI therapy. Nutritional counseling will be provided to all patients every two weeks throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed advanced NSCLC and an EGFR mutation who are eligible for TKI treatment.
Not a fit: Patients who are currently receiving other anti-cancer therapies or have uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce diarrhea in lung cancer patients undergoing TKI therapy, improving their quality of life and treatment adherence.
How similar studies have performed: While similar approaches have been explored, this specific combination of glutamine and L. reuteri in the context of TKI therapy for NSCLC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City, Mexico City
- Instituto Nacional de Cancerologia de Mexico — Mexico City, Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Oscar G Arrieta Rodriguez, M.D., M.Sc. — Instituto Nacional de Cancerología de México
- Study coordinator: Oscar G Arrieta Rodriguez, M.D., M.Sc.
- Email: ogar@unam.mx
- Phone: 556280400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.