Creatine and Cognitive Health in Patients With Early-stage Breast Cancer During and After Chemoth… (NCT07372144) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Creatine and Cognitive Health in Patients With Early-stage Breast Cancer During and After Chemotherapy Treatment
Brazil227 participantsStarted 2026-08-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years.
* Histologically confirmed invasive breast cancer (stages I-III).
* Indication for neoadjuvant or adjuvant chemotherapy containing an anthracycline or a taxane.
* Targeted therapies and hormone therapy are permitted according to clinical indication.
* Ability to provide informed consent and comply with study procedures.
* ECOG performance status 0-2.
* Ability to maintain adequate hydration.
Exclusion Criteria:
* Prior neurologic conditions that may impair cognitive assessment, including previous stroke, dementia, traumatic brain injury with neurologic sequelae, or other neurologic disorders affecting cognition.
* Uncorrected sensory impairments that preclude cognitive assessment and/or completion of study instruments.
* History of uncontrolled psychiatric disorders that may interfere with cognitive evaluation.
* Creatinine clearance \<60 mL/min, calculated using the Cockcroft-Gault formula.
* Known liver disease.
* Pregnancy.
* Heart failure.
* Presence of ascites.
* Inflammatory bowel disease.
* Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs).
* Lactation.
* Chronic use of immunosuppressive agents, including doses greater than 10 mg/day or equivalent.
* Prior chronic creatine supplementation within the last 3 months.
* Known allergy to any component of the supplement or placebo.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in patient-reported cognitive function
Timeframe: Baseline and 1 month after completion of chemotherapy