Chemotherapy-induced Nausea and Vomiting, Colorectal Cancer
Conditions
Brief summary
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.
Interventions
DRUGAprepitant+Tropisetron
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)
DRUGDexamethasone+Tropisetron
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)
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of colorectal cancer * No prior chemotherapy and scheduled to receive FOLFOX chemotherapy (oxaliplatin,leucovorin and 5-fluorouracil) * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2 * Laboratory index: Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥ 1.5×10\^9/L, Platelet Count ≥ 75×10\^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases), Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance\>60ml/min * Be able to read, understand and complete the questionnaire and diary * Be able to understand the study procedures and sign informed consent.
Exclusion criteria
* Treatment with any other study medicine within 4 weeks before enrollment. * Nausea or vomiting ≤ 24 hours prior to registration * Ongoing emesis due to obstruction of digestive tract * Concurrent use of olanzapine, phenothiazine or amifostine * Female with pregnancy or lactation * Severe cognitive compromise * Known history of CNS disease (e.g. brain metastases, seizure disorder) * Concurrent abdominal radiotherapy * Chronic alcoholism * Known hypersensitivity to aprepitant, tropisetron, or dexamethasone. * Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months. * History of uncontrolled diabetes mellitus * Serious or uncontroled infection * Known active HIV, viral hepatitis or tuberculosis infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response | Day 1 to Day 5 after chemotherapy | No emetic episodes and no use of rescue medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Vomiting Episode or Use of Rescue Medication | Day 1 to Day 5 after chemotherapy | — |
| Nausea score | Day 1 to Day 5 after chemotherapy | Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire |
| Frequency of rescue medication | 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 |
| Complete response in the acute phase (0-24 hours) | 0 to 24 hours after chemotherapy | No emetic episodes and no use of rescue medication in the acute phase (0-24 h) |
| Complete response in the delay phase (25 hours-120 hours) | Day 2 to Day 5 (25 hours-120 hours) after chemotherapy | No emetic episodes and no use of rescue medication in the delay phase |
Countries
China
Outcome results
None listed