CTRI/2024/10/075636进行中（未招募）3 期
Randomized, double-blind, placebo-controlled study of oral duloxetine in the prevention of acute pain syndrome in patients receiving paclitaxel
Indian Council of Medical Resaerch2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2024年11月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Incidence of acute pain syndrome after paclitaxel administration
研究概览
简要总结
The study starts enrolling patients with any stage of breast cancer who will be scheduled to start with paclitaxel treatment. After screening and registration, enrollment starts if the patient fulfills the inclusion and exclusion criteria. Duloxetine will be administered following paclitaxel infusion for 7 days and four cycles. Endpoints assessment as per the protocol and recruitment will last for 6-9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Commencing paclitaxel at a planned dose of 175 mg/m2 as single-agent chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Study treatment is both planned and able to start within 14 days of randomization
- •Willing and able to comply with all study requirements, including treatment (taking duloxetine orally), timing and/or nature of required assessments.
排除标准
- •The patients with pre-existing chronic pain or peripheral neuropathy
- •History of hypersensitivity to paclitaxel
- •Pregnant or lactating women.
结局指标
主要结局
Incidence of acute pain syndrome after paclitaxel administration
时间窗: At the end of Cycle 1 of paclitaxel (day 14 or end of week 2)
次要结局
- The proportion of patients who develop peripheral neuropathy across the two arms.
研究者
Atul Batra
All India Institute of Medical Science, New Delhi
研究点 (2)
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