The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment: 'The H1-SWITCH Study'
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Clinically relevant hypersensitivity reactions
研究概览
简要总结
In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated.
详细描述
This is a single arm before-after study with a historic control cohort to evaluate the effect of a policy change (i.e. substitution of clemastine IV for cetirizine PO) regarding the premedication scheme on the incidence of HSR during paclitaxel based chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years;
- •Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose
排除标准
- •Prior treatment with a paclitaxel-based regimen;
- •Inability to orally ingest cetirizine
研究组 & 干预措施
Clemastine group
Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and clemastine 2 mg IV
干预措施: Clemastine IV (Drug)
Cetirizine group
Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and cetirizine 10 mg PO
干预措施: Cetirizine (Drug)
结局指标
主要结局
Clinically relevant hypersensitivity reactions
时间窗: During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).
Hypersensitivity reactions grade 3 or higher according to CTCAE v4.03
次要结局
- Hypersensitivity reactions(During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).)
- The difference in the number of paclitaxel dosages until first occurrence of hypersensitivity reactions(During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).)
- The cumulative dose of paclitaxel (mg/m2) administered prior to the moment of hypersensitivity reaction(During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).)
研究者
Roelof W.F. van Leeuwen
Principal investigator
Erasmus Medical Center