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

Condition(s) studied

Investigational drug(s) / intervention(s)

Creatine: Oral creatine monohydrate supplementation administered at a fixed dose of 5 g per day, dissolved in water and taken once daily. The intervention starts 7 days before initiation of neoadjuvant or adjuvant chemotherapy and continues through chemotherapy and up to 12 months after chemotherapy completion. The intervention is designed to evaluate the preventive effect of creatine on chemotherapy-related cognitive impairment, with longitudinal cognitive, clinical, imaging, and translational assessments. The comparator is a matched placebo identical in appearance, taste, and packaging.

Placebo: Oral placebo powder matched in appearance, taste, and packaging to the investigational product, administered once daily dissolved in water. The placebo is initiated 7 days before the start of neoadjuvant or adjuvant chemotherapy and continued through chemotherapy and up to 12 months after chemotherapy completion. The placebo contains no active ingredients and is used as the comparator to assess the preventive effect of creatine supplementation on chemotherapy-related cognitive impairment.

Study 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

Eligibility

Primary outcome measure(s)

• Change in patient-reported cognitive function — Baseline and 1 month after completion of chemotherapy
  Measured by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), version 3, from baseline to 1 month after completion of chemotherapy. A clinically significant cognitive decline is defined as a decrease of at least 7.5 points in the total FACT-Cog score.

Trial sites (1)

More D'Or Institute for Research and Education trials in Brazil

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