Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Oxaliplatin-Induced Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in perceptions of chemotherapy-induced peripheral neuropathy (CIPN)
研究概览
简要总结
This trial studies how well repetitive transcranial magnetic stimulation (rTMS) works in improving neuropathy due to oxaliplatin chemotherapy in patients with stage I-IV cancer. rTMS is designed to change brain activity by introducing small magnetic impulses to the scalp that encourage the brain to change its activity.
详细描述
PRIMARY OBJECTIVES:
I. Examine the effects of the repetitive transcranial magnetic stimulation (rTMS) training program on perceptions of chemotherapy-induced peripheral neuropathy (CIPN) versus placebo (PC) and wait-list control groups (WLC).
SECONDARY OBJECTIVES:
I. Explore changes in cortical activity: Electroencephalography (EEG) brain maps (low resolution electromagnetic tomography) will be assessed over time and compared between groups.
II. Determine if rTMS improves other aspects of CIPN, quality of life (QOL), and mental health (MH) compared to PC and WLC.
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
- Double (Participant, Investigator)
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
- •Patients with stage I-IV cancers who received oxaliplatin chemotherapy
- •Understand and read English, sign a written informed consent, and be willing to follow protocol requirements
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- •Grade 2 or higher neuropathic symptoms according to the National Cancer Institute's 4 point grading scale
- •Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician)
- •Patients must have neuropathic symptoms for a minimum of 3 months
- •No plans to change the type of pain medication (if a patient is on pain medication)
- •Willing to come to MD Anderson for the therapy sessions
排除标准
- •Patients who are taking any antipsychotic medications
- •Patients who have evidence of brain metastases or any with any active central nervous system (CNS) disease at their time of entry into the trial
- •Patients who have ever been diagnosed with bipolar disorder or schizophrenia
- •Patients who have a history of head injury, focal brain lesions, or known seizure activity
- •Patients who are withdrawing from drugs
- •Patients with intracranial implants or a cardiac pacemaker or any device that is not considered magnetic resonance imaging (MRI) safe. Colorectal patients are sometimes prescribed Tramadol to help control the symptoms of CIPN. Tramadol does lower the seizure threshold, however these patients will be considered eligible for the study if they discontinue the drug 48 hours before the baseline and do not use it during the duration of the study
结局指标
主要结局
Change in perceptions of chemotherapy-induced peripheral neuropathy (CIPN)
时间窗: Baseline up to 1 month
Differences between repetitive transcranial magnetic stimulation (rTMS) and placebo (PC) and between rTMS and wait-list control (WLC) will be assessed by Pain Quality Assessment Scale (PQAS). Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point. The Pain Quality Assessment Scale (PQAS) is a 20-item measure developed to quantify quality and intensity of neuropathic pain. It was derived from the Neuropathic Pain Scale and includes symptom descriptors common to people with neuropathic symptoms.\[44\] Our primary outcome will be the 'unpleasantness subscale'.
次要结局
- Change in cortical activity(Baseline up to 1 month)
- Change in perception of improvement in CIPN as assessed by Pain Vigilance and Awareness Questionnaire (PVAQ)(Baseline up to 1 month)
- Change in perception of improvement in CIPN as assessed by Patients' Global Impression of Change (PGIC) questionnaire(Baseline up to 1 month)
- Change in perception of improvement in CIPN as assessed by Edmonton Symptom Assessment System (ESAS) questionnaire(Baseline up to 1 month)
- Change in perception of improvement in CIPN as assessed by Brief Pain Inventory-short form (BPI) questionnaire(Baseline up to 1 month)