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Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant arm | Experimental | Aprepitant + Tropisetron |
|
| Control arm | Active Comparator | Dexamethasone+ Tropisetron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant+Tropisetron | Drug | Patients will receive the chemotherapy drugs oxaliplatin,leucovorin and 5-fluorouracil as well as the following antiemetic drugs: aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus Tropisetron (5mg IV of day1) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | No emetic episodes and no use of rescue medication | Day 1 to Day 5 after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea score | Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 1 to Day 5 after chemotherapy |
| Time to First Vomiting Episode or Use of Rescue Medication | Day 1 to Day 5 after chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhong Deng, M.D. | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35747189 | Derived | Cheng Y, Wu Z, Shi L, Shen C, Zhang J, Hu H, Li W, Cai Y, Xie X, Ling J, Zheng Q, Deng Y. Aprepitant plus palonosetron versus dexamethasone plus palonosetron in preventing chemotherapy-induced nausea and vomiting in patients with moderate-emetogenic chemotherapy: A randomized, open-label, phase 3 trial. EClinicalMedicine. 2022 Jun 3;49:101480. doi: 10.1016/j.eclinm.2022.101480. eCollection 2022 Jul. |
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| Dexamethasone+Tropisetron | Drug | Patients will receive the chemotherapy drugs oxaliplatin, leucovorin and 5-fluorouracil as well as the following antiemetic drugs: Dexamethasone (10 mg IV on day 1 and 5 mg IV days 2, 3) plus Tropisetron (5mg IV of day1) |
|
| Frequency of rescue medication | Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire | Day 1 to Day 5 after chemotherapy |
| Complete response in the acute phase (0-24 hours) | No emetic episodes and no use of rescue medication in the acute phase (0-24 h) | 0 to 24 hours after chemotherapy |
| Complete response in the delay phase (25 hours-120 hours) | No emetic episodes and no use of rescue medication in the delay phase | Day 2 to Day 5 (25 hours-120 hours) after chemotherapy |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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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