Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05852990

Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Nacional de Cancerologia de Mexico

Mexico City, 14080, Mexico

Location status: Recruiting

Location contact

Oscar G Arrieta Rodriguez, M.D., M.Sc.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glutamine plus L. reuteri

Combination Product

Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death

Other names: Glutapak-R

Primary outcomes

  1. 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

  2. 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

  1. Grade of gastrointestinal toxicity

    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.

  2. Measurement of health related quality of life (QoL)

    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.

  3. Measurement of quality of life (QoL) for lung cancer patients

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oscar G Arrieta Rodriguez, M.D., M.Sc.

CONTACT

[email protected]

556280400 ext. 711101

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia de Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 10, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.