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Creatine may shield breast cancer patients from 'Chemo Brain'

NCT ID NCT07372144

Symptom relief Sponsor: D'Or Institute for Research and Education Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether taking creatine supplements daily can prevent or reduce the memory and thinking problems that often come with chemotherapy. About 227 women with early-stage breast cancer will receive either creatine or a placebo, starting before chemo and continuing for a year after. Researchers will track cognitive function through tests and questionnaires, along with brain scans and blood samples.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
creatine monohydrate (5 g per day oral supplement)
What this could lead to
If it works, this could offer a simple, safe way to protect thinking and memory during chemotherapy for breast cancer patients.
What could go wrong
This is a large Phase 3 trial, but it is not yet recruiting. Creatine may not prevent cognitive decline, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 227 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Instituto D'Or de Pesquisa e Ensino de São Paulo

    São Paulo, São Paulo, Brazil

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