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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Diarrhea toxicity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both sexes
- •≥ 18 years old
- •Pathologically confirmed diagnosis of NSCLC
- •Stage IIIB - IV by the American Joint Committee of Cancer Version
- •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.
Arms & Interventions
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.
Intervention: Glutamine plus L. reuteri (Combination Product)
Standard diet
Astringent diet from baseline treatment up to 6 weeks or death.
Outcomes
Primary Outcomes
Diarrhea toxicity
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
Functional Assessment of Chronic Illness Therapy
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.
Secondary Outcomes
- Measurement of health related quality of life (QoL)(Every two weeks, from first dose of TKI therapy up to six weeks.)
- Grade of gastrointestinal toxicity(Every two weeks, from first dose of TKI therapy up to six weeks.)
- Measurement of quality of life (QoL) for lung cancer patients(Every two weeks, from first dose of TKI therapy up to six weeks.)
Investigators
Oscar Gerardo Arrieta Rodríguez
Head of the Thoracic Oncology Unit and Personalized Medicine Laboratory
Instituto Nacional de Cancerologia de Mexico