Clinical Trial

Creatine and Cognitive Health in Patients With Early-stage Breast Cancer During and After Chemotherapy Treatment

Study acronym: IARA
Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to evaluate whether oral creatine supplementation can prevent chemotherapy-related cognitive impairment in patients with early-stage breast cancer undergoing neoadjuvant or adjuvant chemotherapy. The main questions it aims to answer are: * Does creatine supplementation reduce the occurrence and severity of chemotherapy-related cognitive impairment, as measured by patient-reported cognitive function? * Does creatine supplementation preserve objective cognitive performance compared with placebo during and after chemotherapy? Researchers will compare creatine supplementation (5 g/day) with placebo to assess differences in cognitive outcomes, safety, and exploratory biological markers. Participants will: * Receive oral creatine or placebo starting 7 days before chemotherapy and continuing until 12 months after chemotherapy completion * Complete patient-reported cognitive assessments and objective neuropsychological tests at predefined time points * Undergo clinical follow-up for safety and oncologic outcomes * Provide blood samples for biomarker analyses and stool samples for gut microbiota assessment * Undergo brain magnetic resonance imaging at selected study visits
Trial Details
NCT Number NCT07372144
Lead Sponsor D'Or Institute for Research and Education
Conditions Breast Cancer
Enrollment 227 participants
Start Date 2026-08-01
Primary Completion 2028-06-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-28