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

NCT07372144 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2026-01-28

No results posted yet for this 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

Conditions

Interventions

DRUG

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.

OTHER

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.

Sponsors & Collaborators

  • D'Or Institute for Research and Education

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-06-01
Completion
2028-06-01

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07372144 on ClinicalTrials.gov