A Phase I Study to Determine the Dose of Methadone as a First Line Agent in the Treatment of Chronic Neuropathic Cancer Pain
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 7
- 主要终点
- Optimum starting dose
研究概览
简要总结
RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of methadone hydrochloride as first-line therapy in treating patients with chronic neuropathic cancer pain.
详细描述
OBJECTIVES:
Primary
- To determine the optimum starting dose (defined as the dose that does not require modification within the first 4 days of treatment for lack of efficacy or the occurrence of adverse events) of methadone hydrochloride as a first-line opioid treatment in patients with chronic neuropathic cancer pain.
Secondary
- To assess the number and timing of breakthrough analgesic usage.
- To assess the number of episodes of breakthrough pain.
- To assess the total daily dose of methadone hydrochloride.
- To assess the average pain score.
- To determine the safety and adverse event profile of methadone hydrochloride as a first-line opioid in the treatment of chronic neuropathic cancer pain.
- To assess the frequency and severity of sleep disturbance associated with the use of methadone hydrochloride.
- To determine the feasibility of recruiting patients with chronic neuropathic cancer pain in a reasonable time frame for a future phase III study of methadone hydrochloride vs morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: Methadone
Level 1: 1 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA** per day)
Level 2: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
干预措施: methadone hydrochloride (Drug)
Arm A: Methadone
Level 1: 1 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA** per day)
Level 2: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
干预措施: questionnaire administration (Other)
Arm A: Methadone
Level 1: 1 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA** per day)
Level 2: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
干预措施: management of therapy complications (Procedure)
Arm B: Methadone
Level 1: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 2: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 4 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
干预措施: methadone hydrochloride (Drug)
Arm B: Methadone
Level 1: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 2: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 4 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
干预措施: questionnaire administration (Other)
Arm B: Methadone
Level 1: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 2: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 4 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
干预措施: management of therapy complications (Procedure)
结局指标
主要结局
Optimum starting dose
时间窗: 28 days
次要结局
- Adverse events (including respiratory depression) according to NCI CTCAE v3.0 criteria(28 days)
- Frequency and severity of sleep disturbance from pain(28 days)
- Pain control as assessed by the number and timing of breakthrough analgesics, the number of episodes of breakthrough pain, the total daily dose of methadone, and the average pain scores(28 days)
- Feasibility of recruiting patients(28 days)