Investigation of Somatosensory Predictors of Response to Pregabalin in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Spontaneous Pain Intensity as a Function of Baseline MPT
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Distal symmetric pain distribution (both feet, with or without pain in hands).
- •The pain appeared during or up to 12 weeks after treatment with oxaliplatin, paclitaxel, docetaxel or any combination of these.
- •Score of 4 or more on DN4 (Douleur Neuropathique 4) neuropathic pain questionnaire
- •Pain duration > 2 months.
- •Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
- •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.
- •Able and willing to sign an IRB-approved written informed consent.
排除标准
- •Hypersensitivity to pregabalin.
- •Current treatment with pregabalin.
- •Current treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or CIPN that may be associated with previous treatment with a vinca alkaloid.
- •History of diabetes mellitus or a neurological disorder with any previous signs of distal symmetric polyneuropathy.
- •Moderate to severe renal failure (Creatinine clearance < 30mL/min, by Cockcroft-Gault formula).
- •ALT (alanine aminotransferase) or AST (aspartate aminotransferase ) > 3 times the upper limit of normal.
- •Planned surgeries or radiation treatment within 10 weeks following study inclusion.
- •Inability to complete pain self-report.
- •Pregnancy or lactation
- •Patients with seizure disorders treated with anticonvulsants
- •Current participation in a trial with another investigational agent.
- •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.
研究组 & 干预措施
Pregabalin
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
干预措施: Pregabalin (Drug)
Pregabalin
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
干预措施: Placebo (Drug)
Placebo
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
干预措施: Pregabalin (Drug)
Placebo
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Spontaneous Pain Intensity as a Function of Baseline MPT
时间窗: 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.
次要结局
- Change in BPI Outcomes (INTERFERENCE)(baseline to week 4)
- Change in NPSI Outcomes(Baseline to week 4)
- Change in Sleep Problem Index (SPI) Outcomes(Baseline to week 4)
- Change in BPI Outcomes (SEVERITY)(Baseline to week 4)
- Number of Patients With Significant Pain Reduction(Baseline to week 4)
- Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)(Baseline to week 4)
研究者
simon.haroutounian
Assistant Professor, Department of Anesthesiology
Washington University School of Medicine