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Pregabalin in CIPN

2019年4月25日 更新者：simon.haroutounian、Washington University School of Medicine

Investigation of Somatosensory Predictors of Response to Pregabalin in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)

The investigators seek to investigate certain patient characteristics that would predict the response to a currently approved analgesic, pregabalin, in patients with chronic pain due to nerve damage caused by chemotherapy. Patients with this painful condition, called chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin. The investigators will recruit potential subjects from both the Siteman Cancer Center and the Washington University Pain Management Center. Those patients who meet the inclusion and satisfy the exclusion criteria will be enrolled. Subjects will undergo mechanical and thermal sensitivity testing on their extremities, will provide quality of life information by completing questionnaires and will receive pregabalin followed by placebo, or placebo followed by pregabalin [crossover design] in order to assess how well the sensory tests predict the analgesic effect of pregabalin (compared to placebo).

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

26

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University School of Medicine/Barnes Jewish Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age >18
  2. Distal symmetric pain distribution (both feet, with or without pain in hands).
  3. The pain appeared during or up to 12 weeks after treatment with oxaliplatin, paclitaxel, docetaxel or any combination of these.
  4. Score of 4 or more on DN4 (Douleur Neuropathique 4) neuropathic pain questionnaire
  5. Pain duration > 2 months.
  6. Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
  7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation.
  8. Able and willing to sign an IRB-approved written informed consent.

Exclusion Criteria:

  1. Hypersensitivity to pregabalin.
  2. Current treatment with pregabalin.
  3. Current treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or CIPN that may be associated with previous treatment with a vinca alkaloid.
  4. History of diabetes mellitus or a neurological disorder with any previous signs of distal symmetric polyneuropathy.
  5. Moderate to severe renal failure (Creatinine clearance < 30mL/min, by Cockcroft-Gault formula).
  6. ALT (alanine aminotransferase) or AST (aspartate aminotransferase ) > 3 times the upper limit of normal.
  7. Planned surgeries or radiation treatment within 10 weeks following study inclusion.
  8. Inability to complete pain self-report.
  9. Pregnancy or lactation
  10. Patients with seizure disorders treated with anticonvulsants
  11. Current participation in a trial with another investigational agent.

  12. Concomitant medication as follows:

    • Subjects treated with gabapentin or other anticonvulsant for neuropathic pain will be required to taper the medication and discontinue for at least 2 weeks prior to study initiation.
    • Patients on antidepressant treatment for pain or depression (TCAs, SSRI, SNRIs etc. will be allowed to continue their medications provided they have been on a stable dose for at least 4 weeks before study initiation. No dose regimen changes of antidepressants will be allowed during the study period.
    • Patients on around-the clock opioid treatment (including tramadol) will be allowed to continue their medication provided they have been on a stable dose for at least 4 weeks before study initiation. The maximum allowed dose of opioid will be equivalent to 60mg oral morphine sulphate. Patients with higher doses will be required to taper down their opioid dose to maximum 60mg oral morphine equivalent, and continue on stable dose for 4 weeks before enrollment in the study. Short-acting opioids for painful CIPN treatment will not be allowed.
    • Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) will be discontinued at least 2 weeks before study initiation. However, low-dose aspirin (≤325mg/day) will be allowed.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Pregabalin
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
药品：Pregabalin
Anticonvulsant
其他名称：
  • 抒情歌
药品：Placebo
Identical, matching inactive substance
安慰剂比较：Placebo
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
药品：Pregabalin
Anticonvulsant
其他名称：
  • 抒情歌
药品：Placebo
Identical, matching inactive substance

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Spontaneous Pain Intensity as a Function of Baseline MPT
大体时间：Baseline to week 4
Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.
Baseline to week 4

次要结果测量

结果测量
措施说明
大体时间
Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)
大体时间：Baseline to week 4
Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain
Baseline to week 4
Change in NPSI Outcomes
大体时间：Baseline to week 4
Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score
Baseline to week 4
Change in BPI Outcomes (SEVERITY)
大体时间：Baseline to week 4
Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity
Baseline to week 4
Change in Sleep Problem Index (SPI) Outcomes
大体时间：Baseline to week 4
Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score
Baseline to week 4
Change in BPI Outcomes (INTERFERENCE)
大体时间：baseline to week 4
Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference
baseline to week 4
Number of Patients With Significant Pain Reduction
大体时间：Baseline to week 4
Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain)
Baseline to week 4

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Washington University School of Medicine

调查人员

  • 首席研究员：Simon Haroutounian, PhD、Washington University School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年4月1日

初级完成 (实际的)

2018年4月2日

研究完成 (实际的)

2018年4月2日

研究注册日期

首次提交

2015年3月4日

首先提交符合 QC 标准的

2015年3月16日

首次发布 (估计)

2015年3月20日

研究记录更新

最后更新发布 (实际的)

2019年5月14日

上次提交的符合 QC 标准的更新

2019年4月25日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 201501067

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