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| Name | Class |
|---|---|
| Noordwest Ziekenhuisgroep | OTHER |
| Rijnstate | UNKNOWN |
| Tergooiziekenhuizen locatie Hilversum | UNKNOWN |
| Ziekenhuis Amstelland |
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In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metoclopramide | Active Comparator |
| |
| dexamethason | Active Comparator |
| |
| palonosetron | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metoclopramide | Drug |
| ||
| dexamethason |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy | Primary efficacy endpoint: the proportion of patients reporting complete response during the overall 24 to 160 hours after initiation of the first cycle of moderately emetogenic chemotherapeutic (MEC). Complete response is defined as no vomiting and nausea and no use of rescue medication. A diary will be used to document the date and time of any emetic episodes and use of rescue medication, as well as daily nausea ratings. | 24 to 160 hours |
| tolerability | Primary tolerability endpoint: the proportion of patients with minimal or no antiemetic therapy-related side effects according to the Dexamethasone Symptom Questionnaire (DSQ) questionnaire, the Abnormal Involuntary Movement Scale (AIMS) and Aprepitant questionnaire during the first cycle of moderately emetogenic chemotherapeutic (MEC). | 24 to 160 hours |
| cost-effectiveness | Primary cost-effectiveness endpoint: total antiemetic medication costs per treatment regimen during the first cycle of Moderately Emetogenic Chemotherapy (MEC). A diary will be used to document the use of antiemetics and rescue medication. Total medication costs will be calculated from this. | 24 to 160 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Centrum Alkmaar | Alkmaar | North Holland | 1815 JD | Netherlands | ||
| Ziekenhuis Amstelland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32735029 | Derived | van der Vorst MJDL, Toffoli EC, Beusink M, van Linde ME, van Voorthuizen T, Brouwer S, van Zweeden AA, Vrijaldenhoven S, Berends JC, Berkhof J, Verheul HMW. Metoclopramide, Dexamethasone, or Palonosetron for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy (MEDEA): A Randomized, Phase III, Noninferiority Trial. Oncologist. 2021 Jan;26(1):e173-e181. doi: 10.1634/theoncologist.2020-0305. Epub 2020 Aug 21. |
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| OTHER |
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|
| palonosetron | Drug |
|
| Amstelveen |
| North Holland |
| 1186 AM |
| Netherlands |
| Gemini Ziekenhuis | Den Helder | North Holland | 1782 GZ | Netherlands |
| Tergooiziekenhuizen | Hilversum | North Holland | 1213 XZ | Netherlands |
| Waterland Ziekenhuis | Purmerend | North Holland | 1441 RN | Netherlands |
| De Heel - Zaans Medisch Centrum | Zaandam | North Holland | 1502 DV | Netherlands |
| Rijnstate | Arnhem | Netherlands |
| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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