A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 469
- 主要终点
- Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item
研究概览
简要总结
RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.
PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of duloxetine hydrochloride in cancer patients with painful chemotherapy-induced (taxane or platinum agent) peripheral neuropathy.
Secondary
- Determine the influence of this drug on peripheral neuropathy-related functional status and quality of life of these patients.
- Describe the differences in duloxetine hydrochloride efficacy when used to treat pain caused by chemotherapy-induced peripheral neuropathy based on the neurotoxic drug and class.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 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/Group A (Duloxetine then Placebo)
Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.
干预措施: duloxetine hydrochloride (Drug)
Arm I/Group A (Duloxetine then Placebo)
Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.
干预措施: placebo (Other)
Arm II/Group B (Placebo then Duloxetine)
Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.
干预措施: duloxetine hydrochloride (Drug)
Arm II/Group B (Placebo then Duloxetine)
Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.
干预措施: placebo (Other)
结局指标
主要结局
Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item
时间窗: Day 1 of Week 1 to Day 1 of Week 6
Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was chosen as the primary outcome based on recommendations from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT). Patients completed the BPI-SF when thinking only about pain from peripheral neuropathy. The Cronbach's alpha reliability for the BPI ranges between 0.77 and 0.91. The comparison of interest was the difference between the 2 treatment groups in pain change during the initial treatment period.
次要结局
- Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score(Day 1 of Week 1 to Day 1 to Week 6)
- Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5(Day 1 of Week 1 to Day 1 of Week 6)
- Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item(Day 1 of Week 8 to Day 1 of Week 13)