Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer

Sun Yat-sen University

Status and phase

Completed

Phase 3

Conditions

Chemotherapy-induced Nausea and Vomiting

Colorectal Cancer

Treatments

Drug: Dexamethasone+Tropisetron

Drug: Aprepitant+Tropisetron

Study type

Interventional

Funder types

Other

Identifiers

NCT02909478

GIHSYSU12

Details and patient eligibility

About

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.

Enrollment

315 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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