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NCT Number: NCT07372144

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Creatine

Drug

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

Other

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Intituto D'Or de Pesquisa e Ensino São Paulo

CONTACT

[email protected]

[email protected]

Sponsors and collaborators

Lead sponsor

D'Or Institute for Research and Education

Other

Registry information

Official study 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.

Acronym: IARA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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