JPRN-jRCTs031220008招募中2 期
Exploratory study investigating the efficacy, safety of prophylactic olanzapine for opioid-induced nausea and vomiting in patients with cancer - JORTC-PAL20
Satomi Eriko0 个研究点目标入组 35 人开始时间: 2022年4月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically or clinically malignant disease
- •-An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- •-Patients with moderate to severe cancer pain needed to treat with opioid analgesics as morphine, oxycodone,hydromorphone, etc
- •-Ability to provide informed written consent
- •-An age of > =18 years
- •-Capable to take medicine orally
- •-A life expectancy of 4 weeks or longer
- •-Able to complete study assessments and complying with the study procedures
排除标准
- •-Diabetes mellitus
- •-Had vomiting or nausea (> =CTCAE grade2)
- •-Symptomatic intracranial disease as brain metastasis,nerve dissemination
- •-Had received radiotherapy to the head, abdomen, or pelvis within 6 days before and during the study period
- •-Had received new drugs with emetic or antiemetic action within 48 hours before study initiation
- •-Had received regular strong opioid analgesics within 1 month before study initiation
- •-Had a history of hypersensitivity or any contraindication to olanzapine
- •-Had received new chemotherapeutic agents within 1 week before treatment with the study drug and during the study period.
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