Last updated: May 2, 2023
Sponsor: Instituto Nacional de Cancerologia de Mexico
Overall Status: Active - Recruiting
Phase
3
Condition
Hyponatremia
Bowel Dysfunction
Colic
Treatment
Glutamine plus L. reuteri
Clinical Study ID
NCT05852990
CEI/1565/21 INCAN/CEI/0074/22
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 orpsychiatric disorder that, in the investigator´s opinion, would limit the ability ofan individual to meet the requirements of the study or which affects theinterpretability of the results.
- Active hepatitis virus infection (any serotype) or chronic infection with a potentialrisk of reactivation evaluated through a serological panel.
- Active HIV infection.
- Breastfeeding.
Study Design
Total Participants: 28
Treatment Group(s): 1
Primary Treatment: Glutamine plus L. reuteri
Phase: 3
Study Start date:
March 01, 2022
Estimated Completion Date:
December 12, 2023
Study Description
Connect with a study center
Instituto Nacional de Cancerologia de Mexico
Mexico City, 14080
MexicoActive - Recruiting
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