Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN).
Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN.
详细描述
Primary Objectives:
Objective 1 (Primary Objective): to examine preliminary baseline and serial electrophysiological markers associated with the onset and development of CIPN by tracking brain activity and CIPN symptoms throughout chemotherapy treatment.
Secondary Objectives:
Objective 2 (Secondary Objective): To preliminarily evaluate whether a clBCI program can regulate changes in EEG that are associated with CIPN while participants are undergoing chemotherapy.
Exploratory Objective: Explore whether there are associations between change in brain function and subjective report of CIPN.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Objective 1 Inclusion criteria
- •Participants must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
- •ECOG Performance Status of 0-2;
- •Willing to come to MD Anderson for the imaging sessions.
- •Are 18 years of age or above.
- •Have a diagnosis of breast cancer.
- •will receive chemotherapy including doxorubicin, cyclophosphamide, docetaxel, or paclitaxel;
- •Objective 2 Inclusion criteria:
- •1) Inclusion criteria: Identical to Objective 1 and are willing to participate in the therapy sessions at their homes.
排除标准
- •Objective 1 Exclusion criteria:
- •Participants who are taking any antipsychotic medications.
- •With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
- •Have ever been diagnosed with bipolar disorder or schizophrenia.
- •Known, previously diagnosed peripheral neuropathy from any causes and
- •A history of head injury or who have known seizure activity.
- •Objective 2 Exclusion criteria
- •1) Same exclusion criteria as in Objective
- •Medication usage will be tracked for patients in all groups. Once prescribed, participants must remain on a stable course of medications throughout the course of chemotherapy.
研究组 & 干预措施
Cohort 1 - First 30 Participants
The first 30 participants make up Cohort 1. You will have an EEG and complete one questionnaire prior to your first dose of chemotherapy and once monthly until the end of your chemotherapy (for a maximum of 6 measurements).
干预措施: Electroencephalogram (EEG) (Diagnostic Test)
Cohort 2 - Participants 31-45
Participants 31-45 make up Cohort 2. You will have an EEG,and complete a questionnaire before and after your chemotherapy regimen. Participants will also have a treatment called closed-loop brain-computer interface (clBCI) training twice a week for the 2 weeks leading up to starting chemotherapy, and then twice a week during chemotherapy, for a maximum of 32 sessions, which you will be able to do at home.
干预措施: Electroencephalogram (EEG) (Diagnostic Test)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点