The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 23
- 主要终点
- Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
研究概览
简要总结
RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in treating peripheral neuropathy caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy in patients with cancer.
详细描述
OBJECTIVES:
- Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer.
- Compare symptom distress, mood states, functional abilities, and overall quality of life of patients treated with these agents.
- Determine the toxic effects of lamotrigine in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to neurotoxic chemotherapy received (taxanes vs platinum-based compounds vs vinca alkaloids vs combination vs other), status of neurotoxic chemotherapy (actively receiving therapy vs discontinued or completed), and duration of pain or neuropathy symptoms (1-3 months vs 3-6 months vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I - lamotrigine
Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks in the absence of unacceptable toxicity.
Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks.
Patients are followed at 3-7 days.
干预措施: lamotrigine (Drug)
Arm II - placebo
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks.
Treatment continues for 10 weeks in the absence of unacceptable toxicity.
Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks.
Patients are followed at 3-7 days.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
时间窗: From baseline to week 10
The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below. The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.
Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
时间窗: From baseline to week 10
The change in mean score for average daily pain from baseline to week 10 using the European Cooperative Oncology Group (ECOG) neuropathy scale (ENS) are reported below. The ENS scale goes from 0 to 3 with 0=none, 1=mild paresthesias, 2=mild or moderate sensory loss and/or moderate paresthesias, and 3=severe sensory loss or paresthesias that interfere with function.
次要结局
- The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10(From baseline to week 10)
- Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline](From baseline to week 10)
- Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline](From baseline to week 10)
- Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline](From baseline to week 10)
- Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline](From baseline to week 10)
- Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline](From baseline to week 10)
- Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline](From baseline to week 10)
- Change in POMS Total Score [Week 10 Minus Baseline](From baseline to week 10)