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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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
Instituto Nacional de Cancerologia de Mexico
RECRUITING
Mexico City
Contact Information
Primary
Oscar G Arrieta Rodriguez, M.D., M.Sc.
ogar@unam.mx
556280400
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2027-12-12
Participants
Target number of participants: 28
Treatments
Experimental: Intervention diet
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.
No_intervention: Standard diet
Astringent diet from baseline treatment up to 6 weeks or death.
Sponsors
Leads: Instituto Nacional de Cancerologia de Mexico

This content was sourced from clinicaltrials.gov

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