Prophylactic Duloxetine For Prevention of Paclitaxel Induced Peripheral Neuropathy A Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
研究概览
简要总结
This study is a randomized, open label, parallel group, single centre trial comparing the efficacy and safety of prophylactic duloxetine 30 mg once daily versus standard care alone for the prevention of paclitaxel-induced peripheral neuropathy. The study will be conducted over a period of 13 months at a tertiary care oncology centre in India. A total of 116 patients with solid tumors receiving paclitaxel-based chemotherapy will be enrolled and randomized in a 1:1 ratio. The primary outcome measure will be the change in patient-reported neuropathy symptoms as assessed by the EORTC QLQ-CIPN20 score from baseline to four weeks after completion of paclitaxel therapy. Secondary outcome measures will include the incidence of clinician-graded peripheral neuropathy (NCI-CTCAE version 5.0), the proportion of patients requiring paclitaxel dose modification due to neurotoxicity, and the safety and tolerability of duloxetine during chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients (age more than or equal to 18 years) with histologically confirmed solid tumor (breast, ovarian, lung) scheduled to receive paclitaxel based chemotherapy.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Adequate bone marrow, hepatic, and renal function.
排除标准
- •Pre-existing peripheral neuropathy of any etiology (NCI-CTCAE Grade more than or equal to 2)
- •History of significant psychiatric illness (bipolar disorder, active major depressive disorder).
- •Uncontrolled narrow-angle glaucoma.
- •Severe hepatic impairment (as defined by the investigator).
- •Current use of medications with significant serotonergic effects (SSRIs, SNRIs, tramadol) within 30 days of randomization.
- •Pregnancy or breastfeeding.
研究者
Dr Arjuhn R
Kovai Medical Center and Hospital