Clincosm LogoSign in Get a demo

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

Sponsor
Instituto Nacional de Cancerologia de Mexico (Other)
Overall Status
Recruiting
CT.gov ID
NCT05852990
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
21.4
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Glutamine plus L. reuteri
 Phase 3

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
Anticipated Enrollment :
28 participants
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.Patients with Non-Small Cell Lung Cancer and EGFR Mutation receiving first or second generation-TKI therapy.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Combination Product: Glutamine plus L. reuteri
Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death
Other Names:
  • Glutapak-R

    		•
    No Intervention: Standard diet

    Astringent diet from baseline treatment up to 6 weeks or death.

    Outcome Measures

    Primary Outcome Measures

    1. Diarrhea toxicity [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 [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 Outcome Measures

    1. Grade of gastrointestinal toxicity [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) [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    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 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Nacional de Cancerologia de Mexico Mexico City Mexico 14080

    Sponsors and Collaborators

    • Instituto Nacional de Cancerologia de Mexico

    Investigators

    • Principal Investigator: Oscar G Arrieta Rodriguez, M.D., M.Sc., Instituto Nacional de Cancerología de México

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Oscar Gerardo Arrieta Rodríguez, Head of the Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerologia de Mexico
    ClinicalTrials.gov Identifier:
    NCT05852990
    Other Study ID Numbers:
    • CEI/1565/21 INCAN/CEI/0074/22
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Oscar Gerardo Arrieta Rodríguez, Head of the Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerologia de Mexico
    Non-Small Cell Lung Cancer
    EGFR mutation
    Glutamine
    Lactobacillus reuteri
    standard-care diet
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Diarrhea

    Study Results

    No Results Posted as of May 10, 2023