Instituto Nacional de Cancerologia de Mexico
Mexico City, 14080, Mexico
Location status: Recruiting
Location contact
Oscar G Arrieta Rodriguez, M.D., M.Sc.
CONTACT
NCT Number: NCT05852990
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 3
Mexico City, 14080, Mexico
Location status: Recruiting
Oscar G Arrieta Rodriguez, M.D., M.Sc.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death
Other names: Glutapak-R
Time frame: every two weeks, from first dose of TKI therapy up to six weeks.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Instituto Nacional de Cancerologia de Mexico
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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