Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstituto Nacional de Cancerologia de Mexico
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Both sexes
≥ 18 years old
Pathologically confirmed diagnosis of NSCLC
Stage IIIB - IV by the American Joint Committee of Cancer Version 8.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Glutamine plus L. reuteri
Combination productGlutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Intervention dietExperimental treatment 1 intervention
Group B: Standard dietNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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.2
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.3
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.Sponsors and contacts
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Source ClinicalTrials.gov