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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909478
• Other study ID #: GIHSYSU12
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: December 31, 2019
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Colorectal Cancer
• Colorectal Neoplasms
• Nausea
• Vomiting

Intervention

Drug:
• Aprepitant+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)
• Dexamethasone+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)

Locations

Country	Name	City	State
China	Gastrointestinal Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response	No emetic episodes and no use of rescue medication	Day 1 to Day 5 after chemotherapy
Secondary	Nausea score	Nausea scores measured by the Nausea and Vomiting Daily Diary/Questionnaire	Day 1 to Day 5 after chemotherapy
Secondary	Time to First Vomiting Episode or Use of Rescue Medication		Day 1 to Day 5 after chemotherapy
Secondary	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
Secondary	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
Secondary	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