Standard vs extended four-drugs for chemotherapy-induced nausea and vomiting prophylaxis in hematopoietic stem cell transplant (SENVIT): A phase III randomized control trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- 1A) Complete Response
研究概览
简要总结
This trial is to compare two prophylactic antiemetic regimens in the setting of hematopoietic stem cell transplant (HSCT)
Purpose: To compare the chemotherapy induced nausea and vomiting rates between standard 4 drugs vs extended 4 drugs in patients undergoing HSCT
Hypothesis: Extended 4 drugs improves the chemotherapy induced nausea and vomiting rate by at least 20% as compared to standard 4 drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 12yrs- 65 yrs.
- •undergoing: a.
- •Conditioning for autologous hematopoietic stem cell transplant b.
- •Conditioning for allogenic hematopoietic stem cell transplant
- •Weight ≥ 30 kg.
排除标准
- 未提供
结局指标
主要结局
1A) Complete Response
时间窗: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.
Complete response (CR) was defined as absence of vomiting/ retching and no more than mild nausea during the specified phase.
时间窗: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.
1B) Vomiting counts
时间窗: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.
Number of vomiting episodes separated by at least 5 minutes of nausea and retching free interval
时间窗: From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.
次要结局
- 2) Overall CR rates will be further subdivided into that for acute and delayed phase:
- 3) Complete Protection(No nausea, no vomiting and no use of rescue medications for either nausea or vomiting.)
- 4) Counts of rescue antiemetic doses defined as any therapy given in addition to the standard treatment, for uncontrolled retching/ vomiting, based on clinical judgement(From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.)
- Individual toxicity episodes(From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.)
- 6) Comparison of quality of life scores between the two arms(From initiation of conditioning to 6 days after the last dose of chemotherapy in the conditioning regimen.)
研究者
Debabrata Mohapatra
All India Institute of Medical Sciences