Back to resultsGlutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
Primary Purpose
Non-Small Cell Lung Cancer With EGFR Mutation
Status
Recruiting
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Glutamine plus L. reuteri
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer With EGFR Mutation focused on measuring Non-Small Cell Lung Cancer, EGFR mutation, Glutamine, Lactobacillus reuteri, standard-care diet
Eligibility Criteria
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.
Sites / Locations
- Instituto Nacional de Cancerologia de MexicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention diet
Standard diet
Arm Description
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.
Astringent diet from baseline treatment up to 6 weeks or death.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05852990
First Posted
February 24, 2023
Last Updated
May 2, 2023
Sponsor
Instituto Nacional de Cancerologia de Mexico
1. Study Identification
Unique Protocol Identification Number
NCT05852990
Brief Title
Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancerologia de Mexico
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer With EGFR Mutation
Keywords
Non-Small Cell Lung Cancer, EGFR mutation, Glutamine, Lactobacillus reuteri, standard-care diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Patients with Non-Small Cell Lung Cancer and EGFR Mutation receiving first or second generation-TKI therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard diet
Arm Type
No Intervention
Arm Description
Astringent diet from baseline treatment up to 6 weeks or death.
Intervention Type
Combination Product
Intervention Name(s)
Glutamine plus L. reuteri
Other Intervention Name(s)
Glutapak-R
Intervention Description
Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death
Primary Outcome Measure Information:
Title
Diarrhea toxicity
Description
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.
Title
Functional Assessment of Chronic Illness Therapy
Description
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 Outcome Measure Information:
Title
Grade of gastrointestinal toxicity
Description
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.
Title
Measurement of health related quality of life (QoL)
Description
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.
Title
Measurement of quality of life (QoL) for lung cancer patients
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar G Arrieta Rodriguez, M.D., M.Sc.
Phone
556280400
Ext
711101
Email
ogar@unam.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar G Arrieta Rodriguez, M.D., M.Sc.
Organizational Affiliation
Instituto Nacional de Cancerología de México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cancerologia de Mexico
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar G Arrieta Rodriguez, M.D., M.Sc.
12. IPD Sharing Statement
Citations:
PubMed Identifier
22387006
Citation
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Results Reference
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PubMed Identifier
21565398
Citation
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Results Reference
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PubMed Identifier
23399908
Citation
Walters S, Maringe C, Coleman MP, Peake MD, Butler J, Young N, Bergstrom S, Hanna L, Jakobsen E, Kolbeck K, Sundstrom S, Engholm G, Gavin A, Gjerstorff ML, Hatcher J, Johannesen TB, Linklater KM, McGahan CE, Steward J, Tracey E, Turner D, Richards MA, Rachet B; ICBP Module 1 Working Group. Lung cancer survival and stage at diagnosis in Australia, Canada, Denmark, Norway, Sweden and the UK: a population-based study, 2004-2007. Thorax. 2013 Jun;68(6):551-64. doi: 10.1136/thoraxjnl-2012-202297. Epub 2013 Feb 11.
Results Reference
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PubMed Identifier
32493068
Citation
Secombe KR, Van Sebille YZA, Mayo BJ, Coller JK, Gibson RJ, Bowen JM. Diarrhea Induced by Small Molecule Tyrosine Kinase Inhibitors Compared With Chemotherapy: Potential Role of the Microbiome. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420928493. doi: 10.1177/1534735420928493.
Results Reference
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PubMed Identifier
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Citation
Achamrah N, Dechelotte P, Coeffier M. Glutamine and the regulation of intestinal permeability: from bench to bedside. Curr Opin Clin Nutr Metab Care. 2017 Jan;20(1):86-91. doi: 10.1097/MCO.0000000000000339.
Results Reference
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PubMed Identifier
22489794
Citation
Sanchez-Lara K, Turcott JG, Juarez E, Guevara P, Nunez-Valencia C, Onate-Ocana LF, Flores D, Arrieta O. Association of nutrition parameters including bioelectrical impedance and systemic inflammatory response with quality of life and prognosis in patients with advanced non-small-cell lung cancer: a prospective study. Nutr Cancer. 2012;64(4):526-34. doi: 10.1080/01635581.2012.668744. Epub 2012 Apr 10.
Results Reference
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PubMed Identifier
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Citation
Arrieta O, Michel Ortega RM, Villanueva-Rodriguez G, Serna-Thome MG, Flores-Estrada D, Diaz-Romero C, Rodriguez CM, Martinez L, Sanchez-Lara K. Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study. BMC Cancer. 2010 Feb 21;10:50. doi: 10.1186/1471-2407-10-50.
Results Reference
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Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC
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