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Trial Title:
Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
NCT ID:
NCT05852990
Condition:
Non-Small Cell Lung Cancer With EGFR Mutation
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Diarrhea
Conditions: Keywords:
Non-Small Cell Lung Cancer
EGFR mutation
Glutamine
Lactobacillus reuteri
standard-care diet
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Patients with Non-Small Cell Lung Cancer and EGFR Mutation receiving first or second
generation-TKI therapy.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Glutamine plus L. reuteri
Description:
Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death
Arm group label:
Intervention diet
Other name:
Glutapak-R
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto Nacional de Cancerologia de Mexico
Address:
City:
Mexico City
Zip:
14080
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Oscar G Arrieta Rodriguez, M.D., M.Sc.
Start date:
March 1, 2022
Completion date:
December 12, 2023
Lead sponsor:
Agency:
Instituto Nacional de Cancerologia de Mexico
Agency class:
Other
Source:
Instituto Nacional de Cancerologia de Mexico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05852990
