Breast CancerPhase 3IARANCT07372144
Creatine and Cognitive Health in Patients With Early-stage Breast Cancer During and After Chemotherapy Treatment
A Phase 3 study testing Creatine in people with Breast Cancer, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Creatine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2026to 1 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Intituto D'Or de Pesquisa e Ensino São Paulo contact
Brazil1 site
Instituto D'Or de Pesquisa e Ensino de São Paulo
São Paulo, São Paulo
Instituto D'Or de Pesquisa e Ensino IDOR, pesquisaclinica@idor.org, oncologia.projetos@idor.org
About this study
Official title: Phase III, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of Creatine Supplementation in Attenuating Chemotherapy-related Cognitive Decline in Patients With Early-stage Breast Cancer Undergoing Chemotherapy.
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?
Read more
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
- Breast Cancer
- Being tested
- Creatine, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDrug
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.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Arm A: Placebo | Placebo comparator | Participants assigned to this arm will receive a placebo powder matched in appearance, taste, and packaging to the investigational product. The placebo will be administered orally once daily, dissolved in water, starting 7 days before the first cycle of chemotherapy and continuing until 12 months after completion of chemotherapy. Receives: Other: Placebo |
| Arm B: Creatine Supplementation | Active comparator | Participants assigned to this arm will receive oral creatine monohydrate at a dose of 5 g per day, dissolved in water and administered once daily. Treatment will begin 7 days before the first cycle of chemotherapy and will continue until 12 months after completion of chemotherapy. Receives: Drug: Creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported cognitive function
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.
Measured: Baseline and 1 month after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Rodrigues da Cunha Colombo Bonadio, D'Or Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372144
- Sponsor's protocol ID
- IARA NUP 25000.193607/2025-11
- Acronym
- IARA
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of Creatine Supplementation in Attenuating Chemotherapy-related Cognitive Decline in Patients With Early-stage Breast Cancer Undergoing Chemotherapy.
- ClinicalTrials.gov ID
- NCT07372144
- Acronym / sponsor ID
- IARA / IARA NUP 25000.193607/2025-11
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Placebo | Placebo comparator | Other: PlaceboParticipants assigned to this arm will receive a placebo powder matched in appearance, taste, and packaging to the investigational product. The placebo will be administered orally once daily, dissolved in water, starting 7 days before the first cycle of chemotherapy and continuing until 12 months after completion of chemotherapy. |
| Arm B: Creatine Supplementation | Active comparator | Drug: CreatineParticipants assigned to this arm will receive oral creatine monohydrate at a dose of 5 g per day, dissolved in water and administered once daily. Treatment will begin 7 days before the first cycle of chemotherapy and will continue until 12 months after completion of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineOral 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. | Drug | Arm B: Creatine Supplementation |
| PlaceboOral 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. | Other | Arm A: Placebo |
Primary outcome
Change in patient-reported cognitive function
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Intituto D'Or de Pesquisa e Ensino São Paulo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Creatine in people with Breast Cancer, run by D'Or Institute for Research and Education at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Intituto D'Or de Pesquisa e Ensino São Paulo (pesquisaclinica@idor.org, oncologia.projetos@idor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported cognitive function (time frame: Baseline and 1 month after completion of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.