A Double Blind Placebo Controlled Crossover Pilot Trial of Sativex With Open Label Extension for Treatment of Chemotherapy Induced Neuropathic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in the NRS-PI from baseline to the final week of stable dose treatment)
研究概览
简要总结
Chemotherapy is often used to treat cancer and in many cases can cure it or extend life. Unfortunately many of the chemotherapeutic agents used in treating cancer can cause nerve damage, resulting in severe pain involving the extremities. This "neuropathic" pain causes significant suffering in cancer survivors and may also limit the amount of chemotherapy patients are able to tolerate in attempting to treat the cancer. There is evidence that cannabinoids can suppress chemotherapy evoked neuropathy in animal models, in some cases better than morphine. This study proposes to examine the effect of a cannabinoid extract (Sativex) in treatment of neuropathic pain caused by chemotherapy.
详细描述
The problem of neuropathic pain:
A recent review has identified a neuropathic pain prevalence rate of 2-3% in the general population 1. Based on a Canadian population of 30 million, this means that close to one million Canadians suffer with neuropathic pain. Neuropathic pain is one of the most difficult types of persistent pain to treat effectively. No more than 50% 2 of patients with neuropathic pain obtain adequate relief using current treatments. This is related to the fact that there are numerous pathophysiological mechanisms that contribute to neuropathic pain. Neuropathic pain is now understood to involve neural responses in which both peripheral and central mechanisms contribute to the generation of spontaneous pain and evoked aspects including allodynia and hyperalgesia 3-5, Traditional approaches to neuropathic pain have involved the use of oral medications as single agents or in combination (NSAIDs, opioids, anticonvulsants, tricyclic type antidepressants) 6,7. Unfortunately this approach is often inadequate and accompanied by side effects. New treatments are needed for management of neuropathic pain
Neuropathic pain associated with chemotherapy:
Neuropathic pain associated with chemotherapy used for treatment of solid tumors (eg. paclitaxil, vincristine and cis-platin) is particularly resistant to treatment and is a growing clinical problem as chemotherapeutic regimes grow more successful in extending life. This type of neuropathic pain is particularly resistant to treatment and contributes to the overall level of suffering experienced by patients who recovering from cancer treatment with chemotherapy. There is pre-clinical evidence supporting that cannabinoid agonists may be helpful for treatment neuropathic pain caused by chemotherapy.
Cannabinoids in treatment of pain:
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Age >18 years
- •Neuropathic pain beginning after chemotherapy with paclitaxil, vincristine or cis-platin that has been present for 3 months or longer.
- •Presence of allodynia, hyperalgesia or hypoesthesia on sensory testing in the area of pain.
- •Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
- •Medications must have been stable for at least14 days.
- •Ability to follow the protocol
- •Willing and able to give written informed consent.
排除标准
- •Ischemic heart disease
- •Personal history of schizophrenia or psychotic disorder
- •Family history of schizophrenia or psychotic disorder in first degree family member (parent, sibling or child)
- •Allergy to cannabinoids
- •Presence of any other clinically significant medical disorder (other than the cancer requiring chemotherapy) on history or physical exam that would compromise the participants' safety in the trial as judged by the study physician
研究组 & 干预措施
Sativex
干预措施: Sativex (Drug)
结局指标
主要结局
Change in the NRS-PI from baseline to the final week of stable dose treatment)
时间窗: Patients will titrate the dose to a level where they obtain an analgesic effect without limiting side effects (week 3)
Participants gaining a 30% or greater reduction in the NRS-PI
时间窗: Patients will titrate the dose to a level where they obtain an analgesic effect without limiting side effects (week 3)
次要结局
- Secondary outcome measures will include measures in the remaining domains (suggested by IMMPACT). These include SF36, Quantitative sensory examination, Global Impression of Change, PGIC and Patient Satisfaction Scale, PSS(After stable dosing is achieved (week 3))
研究者
Mary Lynch
MD FRCPC
Nova Scotia Health Authority