A Phase 3 interventional study of Glutamine plus L. reuteri in Non-Small Cell Lung Cancer With EGFR Mutation, sponsored by Instituto Nacional de Cancerologia de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Instituto Nacional de Cancerologia de Mexico · Phase 3, Interventional, and Treatment
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.
Patients in the experimental group will receive two sachets of Glutapak-R every twelve hours for up to six weeks alongside treating physician-chosen EGFR therapy. Patients in the control group will receive a standard-of-care diet.
All patients will receive nutritional counseling every two weeks.
Exclusion Criteria:
Astringent diet supplemented with one sachet containing 10 grams of glutamine plus 100 million Colony Forming Units (CFU) of Lactobacillus reueri every 12 hours, from baseline treatment up to 6 weeks or death.
Combination Product: Glutamine plus L. reuteri
Astringent diet from baseline treatment up to 6 weeks or death.
Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death
Also known as: Glutapak-R
Diarrhea toxicity
The diarrhea grade will be determined from 1 to 5 following the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. As shown below: grade 1: Increase of \< 4 stools per day over baseline; mild increase in ostomy output compared to baseline grade 2: Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL. grade 3: Increase of \>= 7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL. grade 4: Life-threatening consequences; urgent intervention indicated grade 5: Death
Time frame: every two weeks, from first dose of TKI therapy up to six weeks.
Functional Assessment of Chronic Illness Therapy
This assessment will be evaluated with a specific scale for diarrhea (FACIT instrument), which consists of 11 items that assign a value of 0 to 4 for each one. Higher the score, the better quality of life related to diarrhea.
Time frame: Every two weeks, from first dose of TKI therapy up to six weeks.
Grade of gastrointestinal toxicity
This outcome will be determined from grades 1 to 5 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for gastrointestinal disorders.
Time frame: Every two weeks, from first dose of TKI therapy up to six weeks.
Measurement of health related quality of life (QoL)
The QoL of patients with cancer will be determined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC QLQ-C30 v3.0) instrument.
Time frame: Every two weeks, from first dose of TKI therapy up to six weeks.
Measurement of quality of life (QoL) for lung cancer patients
The QoL for Lung Cancer patients will be determined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC QLQ-LC13) instrument.
Time frame: Every two weeks, from first dose of TKI therapy up to six weeks.
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Carcinoma, Non-Small-Cell Lung→
Instituto Nacional de Cancerologia de Mexico