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.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Change in patient-reported cognitive function
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study. Participants, investigators, study staff involved in clinical care, outcome assessment, cognitive testing, imaging analyses, laboratory analyses, and data analysis are masked to treatment allocation. Creatine and placebo are identical in appearance, taste, and packaging. Unblinding will occur only if required for participant safety, according to predefined protocol procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Ability to maintain adequate hydration.
排除标准
- •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.
研究组 & 干预措施
Arm A: Placebo
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.
干预措施: Placebo (Other)
Arm B: Creatine Supplementation
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.
干预措施: Creatine (Drug)
结局指标
主要结局
Change in patient-reported cognitive function
时间窗: 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.
次要结局
未报告次要终点
研究者
Renata Rodrigues da Cunha Colombo Bonadio
Doctor, Principal Investigator
D'Or Institute for Research and Education