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

Plain English Summary

Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC is a Phase 3 clinical trial sponsored by Instituto Nacional de Cancerologia de Mexico studying Non-Small Cell Lung Cancer With EGFR Mutation. This trial tests if a special diet with glutamine and a probiotic (Lactobacillus Reuteri) can prevent diarrhea in advanced lung cancer patients receiving a specific type of treatment called TKI therapy. It is for adult patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation (EGFR) and who are starting or continuing TKI treatment. Participants will follow a special diet with supplements for up to 6 weeks, and their diarrhea and quality of life will be monitored. The alternative is to receive standard care without these specific supplements, which may include anti-diarrheal medications if diarrhea occurs. The trial aims to enroll 28 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of advanced non-small cell lung cancer (Stage IIIB-IV). Patients who are candidates for or currently receiving EGFR-TKI treatment (a type of targeted therapy). Individuals with a good general health status (ECOG score of 0-2) and an expected life expectancy of more than eight weeks. Patients cannot have active infections, be on other cancer treatments, or be participating in other clinical trials within the last four weeks. This trial is studying Non-Small Cell Lung Cancer With EGFR Mutation, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will assess how much diarrhea patients experience and how it affects their daily lives, helping to understand if the supplements are effective in reducing this side effect The specific primary outcome measures are: Diarrhea toxicity (every two weeks, from first dose of TKI therapy up to six weeks.); Functional Assessment of Chronic Illness Therapy (Every two weeks, from first dose of TKI therapy up to six weeks.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a common and difficult side effect of TKI therapy for lung cancer, aiming to improve patients' quality of life during treatment. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-Small Cell Lung Cancer With EGFR Mutation, where improved treatment options are needed.

Investor Insight

This trial focuses on a specific patient population with a significant unmet need, potentially offering a new supportive care strategy for TKI therapy, which is a growing area in lung cancer treatment Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if this trial is right for you and what the potential benefits and risks are. Understand that participation involves following a specific diet and taking supplements daily for up to 6 weeks, with regular check-ups. Be prepared for regular assessments of your diarrhea and overall well-being throughout the study period. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 28 participants

Interventions

• COMBINATION_PRODUCT: Glutamine plus L. reuteri — Glutamine plus Lactobacillus reueri twice daily for up to 6 weeks or death

Primary Outcomes

• Diarrhea toxicity (every two weeks, from first dose of TKI therapy up to six weeks.)
• Functional Assessment of Chronic Illness Therapy (Every two weeks, from first dose of TKI therapy up to six weeks.)

Secondary Outcomes

• Grade of gastrointestinal toxicity (Every two weeks, from first dose of TKI therapy up to six weeks.)
• Measurement of health related quality of life (QoL) (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.)

Full 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.

Trial Locations

• Instituto Nacional de Cancerologia de Mexico, Mexico City, Mexico City, Mexico

Frequently Asked Questions

Related Conditions

• Non-Small Cell Lung Cancer
• Lung Cancer
• Gastrointestinal Toxicity
• Diarrhea
• Tyrosine Kinase Inhibitors
• EGFR Mutations
• Targeted Therapy
• Supportive Care
• Cancer Treatment Side Effects
• Probiotics

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