Last updated 34 days ago
Creatine and Cognitive Health in Patients With Early-stage Breast Cancer During and After Chemotherapy Treatment
227 patients around the world
Available in Brazil
D'Or Institute for Research and Education
1Research sites
227Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto D'Or de Pesquisa e Ensino - Sao Paulo
StudyIARA
SponsorD'Or Institute for Research and Education
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07372144
