Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 336
- 试验地点
- 4
- 主要终点
- Change in Pain Quality Assessment Scale (PQAS) unpleasantness score
研究概览
简要总结
This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.
详细描述
PRIMARY OBJECTIVE:
I. Determine if the combination of duloxetine (DL) and neurofeedback (NFB) is superior to DL or NFB alone in treating chemotherapy induced peripheral neuropathy (CIPN).
SECONDARY OBJECTIVES:
I. Determine the optimal number of neurofeedback sessions needed to result in long-term relief of CIPN in a large cohort of cancer survivors and across socioeconomic groups.
II. Examine baseline brain signatures as a predictor of response to neurofeedback (NFB) and to duloxetine and determine who will require more sessions of NFB to achieve relief of symptoms.
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
- None
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 must have the ability to 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
- •Pain score >= 4 on a 0-10 numeric pain scale and/or grade 1-4 neuropathic pain 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 had neuropathic symptoms for a minimum of 3 months
- •No plans to change pain medication regimen during the course of the study
- •Off active chemotherapy treatment for minimum of 3 months
- •Hormonal (e.g., tamoxifen or Arimidex, etc.) and targeted (Tarceva and Avastin, etc.) therapies allowed as long as they will be continued during the course of the study
- •Willing to come to one of the participating cancer centers for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of the main campuses; or can participate in the therapy sessions from MD Anderson regional care centers
- •If participants agree to the Remote Training Option, participants should be willing to receive equipment at their homes and to return the equipment to MDA in case of malfunction or completion of the study
- •If participants agree to the Remote Training Option, participants should be willing to download necessary software to their home computer
- •If participants agree to the Remote Training Option, participants should be willing to allow research staff remote access to their computer to run the neurofeedback program
排除标准
- •Patients who are taking any antipsychotic medications
- •Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy
- •Patients who have ever been diagnosed with bipolar disorder or schizophrenia
- •Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy
- •Patients who have a history of head injury or who have known seizure activity
- •Patients for whom any contraindications of DL are known
- •Patients with suicidal ideation
- •Patients who are already taking duloxetine for peripheral neuropathy
研究组 & 干预措施
Group I (neurofeedback training, duloxetine)
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
干预措施: Duloxetine (Drug)
Group I (neurofeedback training, duloxetine)
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
干预措施: Neurofeedback (Behavioral)
Group I (neurofeedback training, duloxetine)
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group I (neurofeedback training, duloxetine)
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Group III (duloxetine)
Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group II (neurofeedback training)
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.
干预措施: Questionnaire Administration (Other)
Group II (neurofeedback training)
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.
干预措施: Neurofeedback (Behavioral)
Group II (neurofeedback training)
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.
干预措施: Quality-of-Life Assessment (Other)
Group III (duloxetine)
Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
干预措施: Duloxetine (Drug)
Group III (duloxetine)
Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Change in Pain Quality Assessment Scale (PQAS) unpleasantness score
时间窗: Baseline 5 up to week 10
The primary analysis will be a linear model comparing the mean difference in the change of the unpleasantness subscale of the (PQAS)Pain Quality Assessment Scale from baseline to the end of treatment (5 weeks) between the combination arm, the duloxetine (DL), and the neurofeedback (NFB) arm while adjusting for the stratification factor. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.
次要结局
- Change in cancer-related symptoms(Baseline up to 12 months post-treatment)
- Change in PQAS unpleasantness score(Baseline 5 up to week 10)
- Change in physical functioning(Baseline up to 12 months post-treatment)
- Baseline brain signatures as predictors of response to NFB and to DL(Up to week 5)
- Evaluation of patients who will require more sessions of NFB to achieve relief of symptoms(Up to 12 months post-treatment)
- Change in quality of life(Baseline up to 12 months post-treatment)