Management of Nausea and Vomiting Chemotherapy-induced in Normandy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Number of Participants With Acute Nausea and Vomiting
研究概览
简要总结
The objective of this study was to evaluate the various parameters involved in the occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Aged over 18 years
- •With solid tumors or hematologic in first line chemotherapy, administered intravenously,
- •Able to understand the meaning of the questions
- •Having given their written consent to participate in the survey.
排除标准
- •This does not concern patients who:
- •Do not give their consent for participation
- •Do not speak French
- •Suffer from cognitive deficits
- •Are under therapy
- •Must receive a combination of radio-chemotherapy
- •Present an occlusive syndrome
- •Metastases (s) brain (s) clinically symptomatic (s) or radiologically proven (s) or a (of) tumor (s) brain (s)
- •Have been previously treated with chemotherapy
- •Present a cons-indication to corticosteroids, with anti-serotonin or NK1 receptor inhibitors
- •Pregnant or breastfeeding.
结局指标
主要结局
Number of Participants With Acute Nausea and Vomiting
时间窗: 24 hours
acute nausea and vomiting and/or delayed measured by the tool of anti emetic MAT MASCC. Such self-administered questionnaire was found to be sensitive to detect the different dimensions of chemo-induced nausea and vomiting and to perform well against a daily assessment of nausea and vomiting. The MAT questionnaire separately asks for acute (within 24h of initial administration of chemotherapy) and delayed (from 24h to 4 days after chemotherapy) chemo-induced nausea and vomiting by asking the patient to fill out the first page the day after chemotherapy referring to the first 24h following chemotherapy and the second page 4 days after chemotherapy concerning the period from the day after to 4 days after chemotherapy. Clinically significant nausea was defined by reported nausea intensity \>=3 on a 0-10 scale, 10 being the highest intensity of nausea. Clinically significant chemo induced nausea/vomiting was defined by greater than or equal to one nausea episode/vomiting, respectively.
次要结局
未报告次要终点