A Randomized Controlled Study to Compare (EMEND®)to Standard Treatment as Prevention for Delayed Chemotherapy-induced Nausea and Vomiting (CINV) After Myeloablative Therapy for Patients Undergoing Autologous Stem Cell Transplantation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Vomiting and nausea
研究概览
简要总结
Delayed nausea is a common problem after high dose chemotherapy for bone marrow transplantation. This study wants to compare standard prophylactic anti-emetic therapy with the same treatment plus the drug aprepitant (Emend). The hypothesis is that addition of Emend will reduce nausea and vomiting.
详细描述
A single centre randomized placebo-controlled phase II-study with a random assignment to experimental (EXP) or control (CTR) group. All patients with lymphoproliferative diseases ≥18 years of age, scheduled for myeloablative therapy before autologous stem cell transplantation at the Akademiska University Hospital in Uppsala, Sweden, will be included consecutively during one and a half year. A total of 90 patients (45 per treatment arm) will be accrued for this study. They will be invited by mail to participate in the study a couple of weeks before hospital entry. A random assignment to EXP or CTR will be performed by research nurses not participating in any other way in the study. Patients will be stratified for diagnosis which also means myeloablative therapy (lymphoma (BEAC) or myeloma (high-dose melphalan)), and the groups are expected to be similar in size. One box for each diagnosis (lymphoma and myeloma) will contain equal numbers of randomisation cards for the experimental and control groups, randomly mixed within each box. Cards will be picked consecutively by a research nurse not otherwise involved in the study. The EXP group will receive aprepitant (EMEND®) in combination with standard anti-emetic treatment and the CTR group will receive standard anti-emetic treatment. All treatment will be given in the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥18 years
- •Able to communicate in Swedish
- •Diagnosis of lymphoproliferative disease
- •Scheduled for myeloablative therapy and autologous stem cell transplantation
- •Written informed consent
- •Able to swallow oral medications
排除标准
- •Nausea at baseline (immediately before start of chemotherapy)
- •Gastrointestinal obstruction or active peptic ulcer
- •Current illness requiring chronic systemic steroids or requirement for chronic use of antiemetic agent(s)
- •Hypersensitivity to any component of the study regimen
- •Pregnancy or nursing
- •Unrelenting hiccups
- •Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
- •Psychiatric illness or multi-system organ failure
- •Hepatic insufficiency with ASAT, ALAT three times over reference value
- •Renal insufficiency with creatinin value three times over reference value.
研究组 & 干预措施
Standard antiemetic therapy plus placebo
Standard anti-emetic prophylaxis consisting of 1/dexamethasone 6 mg daily during the chemotherapy days and 2/tropisetron (Navoban)5 mg daily during chemotherapy and 2 days after
干预措施: Placebo (Drug)
aprepitant (Emend)
Aprepitant given orally 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after as an addition to standard antiemetic therapy as in the placebo arm.
干预措施: Aprepitant (Emend) (Drug)
结局指标
主要结局
Vomiting and nausea
时间窗: 7 days
The proportion of patients with a complete response (no vomiting and/or only mild nausea and no use of rescue therapy) a/ during chemotherapy and b/ in the delayed phase (up to 7 days after end of chemotherapy).
次要结局
- Safety and tolerability of the aprepitant regimen for CINV(3 weeks)
研究者
Gunnar Birgegard
Prof
Uppsala University Hospital