A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores
研究概览
简要总结
This study's primary objective is to test the hypothesis that a single infusion of subcutaneous lidocaine can cause a clinically useful reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. A clinically useful reduction in pain is defined by either a 2-point reduction (on a 0-10 scale) in the worst pain experienced over a 24-hour period, or a ≥30% reduction in 24-hour opioid requirement. We will use a composite endpoint of reduction in pain without increase in 24-hr opioid requirement or no decrease in pain with a ≥30% reduction in 24-hour opioid requirement.Subjects will receive either lidocaine or placebo, followed at least 1 week later by the alternate agent.
详细描述
Ten mg/kg of lidocaine will be infused subcutaneously via a Baxter infusor over a 5.5 hour period in ambulatory adult cancer patients with a worst pain score of at least 4 out of 10 despite therapy with at least one opioid plus appropriate oral adjuvant analgesic(s).
A clinically useful reduction in pain is defined by either a 2-point reduction (on a 0-10 scale) in the worst pain experienced over a 24-hour period, or a ≥30% reduction in 24-hour opioid requirement.
The secondary objectives are 1) to determine whether any significant toxicities occur as a result of the infusion. For this study significant toxicity is considered as any adverse event which either leads to the infusion being terminated, or which leads to medical intervention, such as prescribing of another medication or equivalent treatment, 2) to determine the effect of Lidocaine infusion on QOL parameters as measured by the Patient Outcome Scale (POS) Questionnaire and 3) to determine the duration of response to lidocaine infusion.
Subjects will fill out Brief Pain Inventory (BPI), Patient Outcome Scale (POS) periodically and medication logs daily while on study.
On Days of treatment the subjects will have vital sign monitoring every 15 minutes for the 1st hour and then periodically as set out in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind performed by pharmacy. Un blinding to occur at end of study. All subjects to be injected with 1 mL of 1% lidocaine subcutaneous prior to the initiation of the study med infusion, which will act as a masking agent.
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
- •Male or female patients 18 years of age or older
- •In or outpatients referred to the BCCA PSMPC Clinics with a diagnosis of cancer
- •Subjects must have somatic, visceral or neuropathic pain related to cancer
- •Pain intensity, measured by a worst pain score over the last 72 hours of ≥4 on a 0-10 numerical rating scale
- •Must have tried at least one opioid medication without adequate response or with significant side-effects for at least one week
- •For those with neuropathic pain, must have also tried at least one adjuvant analgesic, such as a tricyclic (unless contraindicated) or an anticonvulsant without adequate response or with significant side-effects for at least one week
- •Life expectancy of > 3 months
- •Must be able to communicate symptoms indicating potential toxicity of Lidocaine
- •Must have a competent caregiver in the home overnight after each infusion
- •Must be willing to remain within 30 minutes of the Cancer Centre during each infusion
排除标准
- •Clinically significant cardiac disease, i.e, cardiac failure, atrial fibrillation with slow ventricular rate (<60), any degree of heart block
- •New analgesic treatment initiated in time frame which might have effect within one week of study drug.
- •Hyper or hypokalemia.
- •Liver failure (bilirubin ≥ 25 umol/L).
- •Renal failure (eGFR <50% of normal)
- •Uncontrolled hypertension (>160/90).
- •Hypotension (systolic < 90).
- •Uncontrolled seizures.
- •Planned initiation of chemotherapy, radiotherapy or bisphosphonates within 30 days prior to treatment with study drug.
- •Received an investigational drug within 30 days prior to study.
- •History of allergy to lidocaine or other topical, local or infusional anesthetics.
研究组 & 干预措施
Lidocaine
Lidocaine
干预措施: Lidocaine (Drug)
Placebo (D5W)
Placebo first as compared with lidocaine first
干预措施: Placebo (D5W) (Drug)
结局指标
主要结局
Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores
时间窗: 7 days
The primary outcomes measure is a binary variable indicating whether lidocaine caused a reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. Lidocaine will be considered to have caused reduction in cancer pain if the subject had either one of the following episodes and lasting a minimum of 7 days: 1. A 2-point reduction in severity of pain as assessed by the worst pain score in the last 24 hours (question 3) of the Brief Pain Inventory - Short Form (BPI), compared to the BPI pain score at baseline. Or: 2. ≥30% reduction in 24-hour opioid dose.
次要结局
- Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?(At most 6 weeks (duration of study))
- Quality of Life Question: Over the Past 3 Days, Have Other Symptoms e.g. Feeling Sick, Having a Cough or Constipation Been Affecting How You Feel?(At most 6 weeks (duration of study))
- Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment?(At most 6 weeks (duration of study))
- Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You?(At most 6 weeks (duration of study))
- Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends?(At most 6 weeks (duration of study))
- Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed?(At most 6 weeks (duration of study))
- Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person?(At most 6 weeks (duration of study))
- Quality of Life Question: Over the Past 3 Days, How Much Time do You Feel Has Been Wasted on Appointments Relating to Your Healthcare e.g. Waiting Around for Transport or Repeating Tests?(At most 6 weeks (duration of study))
- Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed?(At most 6 weeks (duration of study))
研究者
Pippa Hawley
Palliative Medicine Specialist
British Columbia Cancer Agency