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The study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients over 18 years old with advanced cancer defined as metastatic disease, no curable treatment options. The patients may not have received chemotherapy or irradiation within 4 weeks, no operations within 2 weeks and no general anesthesia within 4 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week | The primary objective is to observe the effect of standard anti-emetics on change in two-item nausea-score from baseline to 24 hours. | From baseline and at 1 week (5-9 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week | Change in nausea CAT-score from baseline to 24 hours and 7 days | 1 week (5-9 days) |
| Nausea at screening from EORTC-QLQ-C15-Pal at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced cancer, who have not received chemo- or radiotherapy in the last 4 weeks prior to screening, will be screened for nausea and/or vomiting following evaluation of the primary inclusion-/exclusion criteria. The patients can be located either in the hospital departments, at home or in a hospice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense Universityhospital | Odense | 5000 | Denmark |
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Prevalence of nausea at time of screening, related to age, cancer-diagnosis and gender
| At baseline |
| Emesis at screening from EORTC-QLQ-C15-Pal at baseline | Prevalence of emesis at time of screening, related to age, cancer-diagnosis and gender | At baseline |
| Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week | Change in other parameters potentially indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life | From baseline and at 1 week (5-9 days) |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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