Clinical trial · Interventional
Creatine and Cognitive Health in Patients With Early-stage Breast Cancer During and After Chemotherapy Treatment
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Creatine | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm A: Placebo
- description
- 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.
- interventionNames
- Other: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Creatine Supplementation
- description
- 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.
- interventionNames
- Drug: Creatine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available