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The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy | No Intervention | The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone | |
| Aprepitant / Fosaprepitant therapy | Experimental | The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant / Fosaprepitant | Drug | Aprepitant: 125 mg PO on day 1 80 mg PO on days 2 to 3 Fosaprepitant: 150 mg IV on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient diary recording nausea, emesis, food ingestion, and rescue therapy | From initiating administration of anticancer agents to day 6 (120 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansai Rosai Hospital | Amagasaki | Hyōgo | 6600064 | Japan | ||
| Kinki Central Hospital |
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| Itami |
| Hyōgo |
| 6640872 |
| Japan |
| Kawasaki Hospital | Kobe | Hyōgo | 6520042 | Japan |
| Nara Hospital Kinki University Faculty of Medicine | Ikoma | Nara | 6300293 | Japan |
| Higashiosaka City General Hospital | Higashiosaka | Osaka | 5788588 | Japan |
| Saito Yukoukai Hospital | Ibaraki | Osaka | 5670085 | Japan |
| Rinku General Medical Center | Izumisano | Osaka | 5988577 | Japan |
| Kaizuka City Hospital | Kaizuka | Osaka | 5970015 | Japan |
| Hannan Chuo Hospital | Matsubara | Osaka | 5800023 | Japan |
| Minoh City Hospital | Minoo | Osaka | 5620014 | Japan |
| Sakai City Hospital | Sakai | Osaka | 5900064 | Japan |
| Osaka Rosai Hospital | Sakai | Osaka | 5918025 | Japan |
| Suita Municipal Hospital | Suita | Osaka | 5640082 | Japan |
| Saiseikai Senri Hospital | Suita | Osaka | 5650862 | Japan |
| Graduate School of Medicine / Faculty of Medicine, Osaka University | Suita | Osaka | Japan |
| Toyonaka Municipal Hospital | Toyonaka | Osaka | 5608565 | Japan |
| Yao Municipal Hospital | Yao | Osaka | 5810069 | Japan |
| Kenporen Osaka Central Hospital | Osaka | 5300001 | Japan |
| Iseikai Hospital | Osaka | 5330022 | Japan |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Osaka | 5378511 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 5400006 | Japan |
| NTT West Osaka Hospital | Osaka | 5430042 | Japan |
| Nissay Hospital | Osaka | 5500012 | Japan |
| Tane General Hospital | Osaka | 5500024 | Japan |
| Osaka Seninhoken Hospital | Osaka | 5520021 | Japan |
| Osaka Koseinenkin Hospital | Osaka | 5530003 | Japan |
| Osaka General Medical Center | Osaka | 5588558 | Japan |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| C579707 | fosaprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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