Methylprednisolone Replacement for Dexamethasone-induced Hiccup
关键词
抽象
日期
| 最后验证: | 10/31/2012 |
| 首次提交: | 01/12/2011 |
| 提交的预估入学人数: | 01/13/2011 |
| 首次发布: | 01/16/2011 |
| 上次提交的更新: | 11/17/2012 |
| 最近更新发布: | 11/19/2012 |
| 实际学习开始日期: | 06/30/2010 |
| 预计主要完成日期: | 06/30/2011 |
| 预计完成日期: | 11/30/2011 |
状况或疾病
干预/治疗
Drug: Methylprednisolone replacement
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Methylprednisolone replacement This study will enroll the patients who were previously experienced dexamethasone-induced hiccup. Patients who experienced dexamethasone-induced hiccup during chemotherapy will enroll to study arm.
Run-in period * Dexamethasone 10mg-20mg q day iv during chemotherapy
▶ measure hiccup and nausea/vomiting severity
Treatment period * Methylprednisolone 60mg-125mg iv during chemotherapy
▶ measure hiccup and nausea/vomiting severity
Response will be evaluated by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) and NRS to hiccup at 24hrs after start methylprednisolone.
Nausea and vomiting will be assessed as CTCAE 4.0 | Drug: Methylprednisolone replacement Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age olderthan 21 - A Patient on chemotherapy who was diagnosed malignant tumor - A Patient who is newly developed hiccup in the course of chemotherapy - A patient with the willingness to comply with the study protocol during the study period and capable of ccomplying with it - A patient who signed the imformed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages Exclusion Criteria: - A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications - A patient with uncontrolled diabetes - A patient who developed uncontrolled serious infection or other uncontrolled serious concomitant diseases - A patient with disease progression after run-in period who is expected to receive another chomotherapeutic agents with different level of emetic risk |
结果
主要结果指标
1. Prevention rate of dexamethasone induced hiccup [24hrs after chemotherapy]
次要成果指标
1. Prevention rate of nausea and vomiting [acute; 24 hours, delayed; 7 days after chemotherapy]
