RecruitingNot ApplicableNCT06892093

Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients

Efficacy and Safety of Probiotics Versus Standard Care in Preventing Diarrhea Induced by Neratinib in Breast Cancer Patients: A Prospective Randomized Controlled Clinical Trial

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

308 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer Diarrhea Caused by Drug Neratinib

Summary

This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib. Study Design: This is a prospective, randomized controlled clinical trial. Participants will be randomly assigned to either a probiotics intervention group or a placebo-controlled group. Both groups will receive prophylactic loperamide according to the FDA-recommended dosing schedule for neratinib-associated diarrhea. Primary Objective: To evaluate the efficacy of probiotics in reducing the incidence and severity of diarrhea in patients receiving Neratinib. Secondary Objectives: This study will also investigate the effects of probiotics on gut microbiota composition and their potential impact on drug efficacy. Study Duration: Enrollment is planned from August 2025 to June 2027 at Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University. Both the intervention and control groups will receive treatment for a total of six weeks (two cycles of three weeks each). No post-treatment observation period is included. Eligibility Criteria: Participants must be diagnosed with HER2-positive breast cancer and scheduled to receive Neratinib. Exclusion criteria include patients with severe gastrointestinal disorders or recent probiotic consumption.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking probiotics (beneficial bacteria supplements) can help prevent or reduce severe diarrhea caused by a breast cancer drug called neratinib, which is known to cause this common and debilitating side effect. **You may be eligible if...** - You are a woman aged 18 or older with HER2-positive breast cancer - You are scheduled to receive neratinib as part of your treatment - Your heart function and blood counts are within acceptable ranges - Your performance status is good (able to carry out daily activities) **You may NOT be eligible if...** - You have already received neratinib and had it cause complications - Your blood counts, liver function, or kidney function are outside normal ranges - You have serious heart problems (e.g., low heart pumping function) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotics

Participants in this group will receive a daily dose of probiotics as an adjunct to standard Neratinib therapy. The probiotics will be administered orally as a granule formulation dissolved in water, for a total duration of 6 weeks (two treatment cycles). Loperamide will be administered prophylactically according to the FDA-recommended schedule to prevent Neratinib-associated diarrhea. The aim is to assess the efficacy of probiotics in reducing Neratinib-induced diarrhea and improving quality of life.

DIETARY_SUPPLEMENTPlacebo

Participants in this group will receive a daily dose of a placebo that is identical in appearance, taste, and administration method to the probiotic granules, in addition to standard Neratinib therapy. The placebo will be administered orally as a granule formulation dissolved in water, for a total duration of 6 weeks. Loperamide will also be administered prophylactically to all participants in accordance with FDA recommendations. This group will serve as a control to evaluate the true effect of probiotics on Neratinib-induced diarrhea.

DRUGLoperamide

All participants will receive prophylactic loperamide to reduce the risk of Neratinib-induced diarrhea. Loperamide will be administered according to the FDA-recommended schedule: 4 mg TID for the first 14 days of treatment, then 4 mg BID from Day 15 to Day 42. This intervention is implemented as a standard supportive therapy and not as a randomized variable.