Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
NCT Number: NCT02909478
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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Notify Me18 year and older
All sexes
Interventional
Phase 3
Guangzhou, Guangdong, 510655, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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)
Time frame: Day 1 to Day 5 after chemotherapy
No emetic episodes and no use of rescue medication
Time frame: Day 1 to Day 5 after chemotherapy
Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire
Time frame: Day 1 to Day 5 after chemotherapy
Time frame: Day 1 to Day 5 after chemotherapy
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
Time frame: 0 to 24 hours after chemotherapy
No emetic episodes and no use of rescue medication in the acute phase (0-24 h)
Time frame: Day 2 to Day 5 (25 hours-120 hours) after chemotherapy
No emetic episodes and no use of rescue medication in the delay phase
Sun Yat-sen University
Other
Steroid-free Regimen With Aprepitant in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer Receiving FOLFOX Chemotherapy: a Randomized Phase 3 Trial
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