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

NCT ID: NCT02909478

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-12-31

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.

Conditions

Chemotherapy-induced Nausea and Vomiting; Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aprepitant arm

Aprepitant + Tropisetron

Group Type: EXPERIMENTAL

Aprepitant+Tropisetron

Intervention Type: DRUG

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)

Control arm

Dexamethasone+ Tropisetron

Group Type: ACTIVE_COMPARATOR

Dexamethasone+Tropisetron

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Deng

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanhong Deng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

Cheng Y, Wu Z, Shi L, Shen C, Zhang J, Hu H, Li W, Cai Y, Xie X, Ling J, Zheng Q, Deng Y. Aprepitant plus palonosetron versus dexamethasone plus palonosetron in preventing chemotherapy-induced nausea and vomiting in patients with moderate-emetogenic chemotherapy: A randomized, open-label, phase 3 trial. EClinicalMedicine. 2022 Jun 3;49:101480. doi: 10.1016/j.eclinm.2022.101480. eCollection 2022 Jul.

Reference Type: DERIVED

PMID: 35747189 (View on PubMed)

Other Identifiers

GIHSYSU12

Identifier Type: -

Identifier Source: org_study_id