A Multidisciplinary Neuroscience Approach to Investigate Cognitive Impairment in Young Patients With Cancer Prospectively
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Performance on clinical neurocognitive tests: Wechlers scale
研究概览
简要总结
The MyBrain study investigates the brain function of children, adolescents and young adults during and after chemo treatment for cancer. The tests include 1) cognitive skills such as memory and attention; 2) the brain's electrical activity; 3) and biological markers related to brain function.
The aim of the study is to better understand the trajectories of cognitive functioning and measures that have been associated with cognitive impairment in patients treated with chemotherapy.
详细描述
Background:
Numerous studies indicate that many patients with cancer, regardless of cancer type, develop cancer-related cognitive impairment (CRCI), which may persist for many years after ended treatment. CRCI can occur regardless of cancer type and most often affects cognitive domains, such as memory, attention processing speed, and executive functions. In daily life, this may manifest as difficulties in attention and concentration, learning, multitasking, mentally organize tasks, and cognitive fatigue. The cognitive impact of cancer and cancer treatments for non-CNS patients has been shown with several research disciplines, such as neuropsychological tests, neuroimaging, biomarkers, and animal studies.
Cognitive impairment affects children, adolescents, and young adults with cancer and their families. Young cancer patients may be particularly vulnerable to cognitive impairment as the brain undergoes development in childhood and continues into the twenties. However, there is a lack of knowledge about when a decrease in cognitive capacity may occur, how long it will persist, and which cognitive domains are affected for children adolescents and young adults with cancer.
Aim:
MyBrain is an explorative study which will explore and describe trajectories of CRCI as measured by neuropsychological assessment, self-reported quality of life and fatigue, brain functioning measured with electroencephalogram (EEG), and biomarkers of neural impairment and inflammation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are newly diagnosed with a non-CNS cancer and will undergo chemotherapy at University Hospital Copenhagen, Rigshospitalet.
- •At the age of 7-29 years at diagnosis
- •Each patient is matched (1:1) with a control participant within 24 months of age. The controls are recruited from the patient's own social circle and can be a friend, partner, or close family (sibling or cousin).
排除标准
- •Unable to speak and understand Danish
- •Severe intellectual disability or mental health disorder that hinders participation
- •Brain metastases,
- •Terminal illness
- •Have had a previous chemotherapy or radiotherapy treatment
结局指标
主要结局
Performance on clinical neurocognitive tests: Wechlers scale
时间窗: T3: 6 months after end of treatment
Scores on the clinical neurocognitive tests (Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Scaled scores range from 0-19, higher = better performance.
次要结局
- Trajectories of resting-state EEG: the power spectrum, absolute theta power(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of resting-state EEG: the power spectrum, relative beta power(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of performance on clinical neurocognitive tests: Conner's Continuous Performance Test(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of resting-state EEG: the power spectrum, absolute alpha power(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of resting-state EEG: the power spectrum, absolute beta power(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of performance on automated cognitive tests(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of fatigue(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of performance on clinical neurocognitive tests: Grooved Pegboard test(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of performance on clinical neurocognitive tests: NEPSY-II, A Developmental Neuropsychological Assesment of Neuropsychological Status(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of quality of life(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of performance on clinical neurocognitive tests: Repeatable Battery for the Assessment of Neuropsychological Status(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of resting-state EEG: the power spectrum, absolute delta power(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of resting-state EEG: the power spectrum, relative delta power(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of resting-state EEG: the power spectrum, relative theta power(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of resting-state EEG: the power spectrum, relative alpha power(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of the ERP oddball test: P300 peak latency(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of serum levels of biomarkers of neurodegeneration and inflammation(T0: within 30 days of diagnosis; T1acb: immediately before and 10-14 days after major chemo treatments, HDM1-3 immediately before and 10-14 days after HDM; T2: end of treatment (2 weeks after final antineoplastic treat.); T3: 6 months after end of treat.)
- Trajectories of the ERP oddball test: P300 amplitude(T0: within 30 days of diagnosis, T2: end of treatment (2 weeks after the final antineoplastic treatment); T3: 6 months after end of treatment)
- Trajectories of cerebrospinal fluid levels of biomarkers of neurodegeneration and inflammation(T0: within 30 days of diagnosis; T1acb: immediately before and 10-14 days after major chemo treatments, HDM1-3 immediately before and 10-14 days after HDM; T2: end of treatment (2 weeks after final antineoplastic treat.); T3: 6 months after end of treat.)
研究者
Lisa Lyngsie Hjalgrim
Principal Investigator
Rigshospitalet, Denmark