Actively Recruiting
Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
Led by Instituto Nacional de Cancerologia de Mexico · Updated on 2026-04-09
28
Participants Needed
1
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both sexes
- At least 18 years old
- Pathologically confirmed diagnosis of non-small cell lung cancer
- Stage IIIB to IV disease according to the American Joint Committee of Cancer Version 8
- Candidates for first or second generation EGFR-TKI treatment
- ECOG performance status score of 2 or less
- Life expectancy greater than eight weeks
- Signed written informed consent
You will not qualify if you...
- Unable to attend the first protocol appointment
- Receiving other anti-cancer treatments
- Participating in other clinical trials within the past four weeks
- Any serious condition, uncontrolled infection, altered mental status, or psychiatric disorder limiting study participation or result interpretation
- Active hepatitis virus infection or chronic infection with risk of reactivation
- Active HIV infection
- Currently breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Cancerologia de Mexico
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
Research Team
O
Oscar G Arrieta Rodriguez, M.D., M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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