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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
315
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)
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Complete response
No emetic episodes and no use of rescue medication
Time frame: Day 1 to Day 5 after chemotherapy
Nausea score
Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire
Time frame: Day 1 to Day 5 after chemotherapy
Time to First Vomiting Episode or Use of Rescue Medication
Time frame: Day 1 to Day 5 after chemotherapy
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
Time frame: 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)
Time frame: 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
Time frame: Day 2 to Day 5 (25 hours-120 hours) after chemotherapy
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