Treatment of Chemotherapy-induced Nausea and Vomiting
关键词
抽象
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.
日期
| 最后验证: | 11/30/2012 |
| 首次提交: | 04/08/2010 |
| 提交的预估入学人数: | 04/08/2010 |
| 首次发布: | 04/11/2010 |
| 上次提交的更新: | 12/11/2012 |
| 最近更新发布: | 12/12/2012 |
| 实际学习开始日期: | 04/30/2010 |
| 预计主要完成日期: | 11/30/2012 |
| 预计完成日期: | 11/30/2012 |
状况或疾病
干预/治疗
Drug: aprepitant (Emend)
Drug: Standard antiemetic therapy plus placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: 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 | Drug: Standard antiemetic therapy plus placebo Placebo will be administered instead of Emend |
| Experimental: 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. | Drug: aprepitant (Emend) Aprepitant will be added to the standard anti-emetic therapy. Emend is given orally, 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
结果
主要结果指标
1. Vomiting and nausea [7 days]
次要成果指标
1. Safety and tolerability of the aprepitant regimen for CINV [3 weeks]
