Observational Study of Delayed Nausea and Vomiting Following Administration of Carboplatin Containing Regimens for Treatment of Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens
研究概览
简要总结
Delayed emesis following administration of carboplatin-based chemotherapy despite prophylaxis with standard antiemetic prophylaxis (5-HT3 and corticosteroid) remains a clinically significant and distressing problem for patients with cancer. The incidence of delayed emesis appears to be higher in women compared to men.
详细描述
All patients will be given the Functional Living Index- Emesis (FLIE), a standardized questionnaire. This is a self-administered questionnaire to assess the impact of nausea and vomiting on the patient's functional living, including physical activities, social and emotional function, and ability to enjoy food and drink. Patients will complete the questionnaire during the 5 days following carboplatin administration (at 24 hours, 48 hours, 72 hours and 96 hours) during their first and third cycles of chemotherapy. The questionnaire should take approximately 10 minutes or less to complete.
Patients will also be interviewed by a trained CRA or research nurse over the telephone 24-48 hours following carboplatin administration in order to assess the severity of the delayed nausea and vomiting.
研究设计
- 研究类型
- Observational
- 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
- •Patients must have newly diagnosed, histologically or cytologically proven cancer, and be scheduled to receive chemotherapy with carboplatin at AUC 5 or above.
- •Patients should receive standard antiemetic prophylaxis prior to carboplatin administration, defined as 5-HT3 antagonist and dexamethasone. We will include only patients whose standard care includes treatment with a carboplatin-containing regimen and who are not being treated with aprepitant (Emend®).
- •After being informed of the treatment involved, patients must give written consent.
- •Entry to this study is open to both men and women and to all racial and ethnic subgroups.
排除标准
- •No prior cytotoxic chemotherapy within the last 5 years.
- •Should not be pregnant.
结局指标
主要结局
Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens
时间窗: After 1st cycle of chemotherapy
Despite appropriate administration of standard 5-HT3 receptor antagonist antiemetic prophylaxis after the first cycle of chemotherapy.
次要结局
- Characterize the incidence of delayed emesis following administration of carboplatin-containing chemotherapy regimens(After 3rd cycle of chemotherapy)
- Characterize the differences in incidence of delayed nausea and vomiting among male and female patients receiving carboplatin.(Through the end of 3 cycles of therapy)
- Assess the need for breakthrough nausea and vomiting control in patients following administration of carboplatin-containing chemotherapy regimens(Through the end of 3 cycles of therapy)