Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis
- Registration Number
- NCT01148264
- Lead Sponsor
- Karin Jordan
- Brief Summary
This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea>25mm on VAS
- signed IC
Exclusion Criteria
- psychiatric disorders
- drug abuse
- pregnancy
- high dose chemotherapy
- treatment with other antiemetic drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description olanzapine olanzapine - metoclopramide metoclopramide -
- Primary Outcome Measures
Name Time Method Clinical benefit rate three days no vomitus, no further rescue medication, nausea \< 25mm on the visual analog scale (VAS) or reduction on the VAS of \>50%
- Secondary Outcome Measures
Name Time Method change in urinary excretion of 5 hydroxy indole acetic acid 5 days measurement in 24 hours urine samples
Quality of life 5 days using EORTC-QLQ-C30
safety five days according to NCI-CTC-AE version4.0
Trial Locations
- Locations (1)
Martin-Luther-University Halle-Wittenberg, Department for Oncology and Hematology, Ernst-Grube-Strasse 40
🇩🇪Halle (Saale), Sachsen-Anhalt, Germany