Glutamine and L. Reuteri to prevent diarrhea in lung cancer patients on TKI therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.