NCT03362073Unknown2 期
A Phase II Study About Efficacy and Safety of the Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients With Refractory Cancer Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
To establish the role of ketamine in hospitalized terminally ill cancer patients with refractory cancer pain, using continuous intravenous infusion of ketamine
详细描述
- There are approximately 20 percent patients of refractory cancer pain, which is troubled with uncontrolled pain though treatment including opioids.
- Ketamine has been showed the performance of Ketamine, N-methyl-D-aspartate (NMDA) receptor blocker, in refractory cancer pain based on prior studies.
- We cannot yet confirm the role of Ketamine comparing the benefit and risk due to incompatible results of prior studies. Additionally, most of prior studies were studied in heterogenous groups, which are from beginning of palliative chemotherapy to terminal status, so role of ketamine was not assessed in homogeneous terminally ill cancer patients. And they has used mostly 'bolus intravenous infusion' or 'continuous subcutaneous infusion (CSCI)', relatively rare in continuous intravenous infusion (CIVI).
- The bolus intravenous method is convenient but is concerned with leading to relatively severe adverse events due to poor general condition of terminally ill cancer patients, the CSCI method is not recommended because of adverse events (AEs) such as skin irritation. On the contrary, the CIVI method using gradual increasing ketamine minimizes AEs and is free of skin irritation. Most of hospitalized terminally ill cancer patients has proper IV access using intravascular devices (chemoport or PICC). So, CIVI method is suitable to hospitalized terminally ill cancer patients.
- This study assess the efficacy and safety of 5-days CIVI gradual dose titration of Ketamine in terminally ill cancer patients with refractory cancer pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Among patients with histologically or cytologically confirmed malignancy, patients with expected survival time of several months or less due to a progressive disease without additional anticancer treatment.
- •Patients with refractory cancer pain, which cases of requesting 4 or more breakthrough analgesics or increase of baseline analgesics (average pain score ≥ 4 or Personalized pain goal) in spite of 120 mg/day or more of intravenous Morphine Equivalent Daily Dose
- •Hospitalized patients with intravascular access during at least 5 days
- •Age 18 or older
- •Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed about all pertinent aspects of the trial prior to enrollment
排除标准
- •Patients who were treated with ketamine for pain control within 6 months
- •Patients who have been treated with radiotherapy within 4 weeks or plan to intervention for pain control during study period
- •Cancer pain cannot be excluded the Opioid induced hyperalgesia
- •Concomitant severe medical, surgical, or disease or problems which were contraindicated to application of Ketamine or have possibilities of unexpected medical problems caused be the Ketamine
- •confirmed or assumed central nervous system lesion which lead to increased intracranial pressure
- •Arrhythmia (supra-ventricular tachycardia, ventricular arrhythmia (frequent premature ventricular contraction, bigeminy, Ventricular tachycardia)
- •history of hemorrhagic stroke or seizure within 3 months
研究组 & 干预措施
Ketamine
Experimental
continuous intravenous infusion of ketamine
干预措施: Ketamine (Drug)
结局指标
主要结局
Overall response rate
时间窗: From date of enrollment until 5 days or drop-out, assess up to 2 years
complete pain response plus partial pain response * Complete pain response is defined as patient reported pain score using numerical rating scale (range 1-10) ≤ 3 or ≤ personalized pain goal (PPG) and receiving less than four rescue analgesic doses for 24 hours, without unacceptable toxicities * Partial pain response is defined as receiving less than four rescue analgesic doses per day without a patient reported pain score using numerical rating scale (range 1-10) ≤ 3 or ≤ personalized pain goal for 24 hr, without unacceptable toxicities
次要结局
- Patient's satisfaction about Ketamine by a newly developed question in this study(at the 5th days or drop-out, assess up to 2 years)
- Change of pain intensity(From date of enrollment until 5 days or drop-out, assess up to 2 years)
- Rate of Ketamine-related adverse events(From date of enrollment until 5 days or drop-out, assess up to 2 years)
- Guardian's satisfaction about Ketamine by a newly developed question in this study(at the 5th days or drop-out, assess up to 2 years)
- Rescue analgesics for breakthrough pain(From date of enrollment until 5 days or drop-out, assess up to 2 years)
- Rate of early discontinuation(From date of enrollment until 5 days or drop-out, assess up to 2 years)
- Overall survival(From date of enrollment until death or discharge/transfer, assess up to 2 years)
研究者
Kwonoh Park, MD phD
Professor, clinical research
Pusan National University Yangsan Hospital
研究点 (1)
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