Anti-emetic Prophylaxis With or Without Dexamethasone

Phase 3

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Drug: Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen; Drug: Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen

• Registration Number: NCT05242874
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

To evaluate the efficacy and safety of a fosaprepitant, tropisetron, and olanzapine antiemetic regimen, with or without dexamethasone, in patients receiving highly emetogenic chemotherapy with epirubicin and cyclophosphamide.

Detailed Description

Patients in this study were randomly assigned in a 1:1 ratio to one of two groups using an interactive response system with permuted blocks of four, stratified by age (\<55 vs. ≥55 years). They received either a three-drug antiemetic regimen with fosaprepitant, tropisetron, and olanzapine (triple group) or a four-drug regimen including fosaprepitant, tropisetron, olanzapine, and dexamethasone (quadruple group). All patients were hospitalized for approximately 120 hours post-chemotherapy, documenting emetic episodes, rescue medication use, and nausea ratings on a Likert scale (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea) in a diary. Rescue therapy was available as needed. Clinical staff monitored adverse events every 24 hours using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Subjects who initiated treatment were followed up for endpoints, including complete response (CR), complete control (CC), total control (TC), quality of life, and safety assessments.

Study Timeline

• Study First Submitted: 2022-01-28
• Study Start: 2022-02-01
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-16
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 442

Inclusion Criteria

1. Breast cancer patients receiving their first anthracycline/cyclophosphamide-based HEC regimen (cyclophosphamide 600 mg/m², epirubicin 90-100 mg/m²); divided doses excluded.
2. No prior chemotherapy.
3. Aged 18-70 years.
4. ECOG performance status 0 or 1.
5. Adequate organ function: (including absolute neutrophil count≥1,500/mm3, WBC count≥3,000/mm3, platelet count≥100,000/mm3, AST< 2.5×the upper limit of normal (ULN), ALT< 2.5×ULN, bilirubin< 1.5×ULN, creatinine< 1.5×ULN).
6. No nausea or vomiting within 24 hours before registration.
7. Negative pregnancy test within 7 days prior (women of childbearing potential).
8. No severe cognitive impairment.
9. No hypersensitivity to fosaprepitant, tropisetron, olanzapine, and dexamethasone.
10. No significant cardiac issues: arrhythmia, recent heart failure, or myocardial infarction within 6 months.
11. No symptomatic brain metastasis or carcinomatous meningitis.
12. No diabetes requiring insulin or oral medication.
13. No use of prohibited medications within 48 hours before registration or during treatment.
14. Informed consent obtained.

Exclusion Criteria

1. History of allergic reactions to study drugs or their analogues.
2. Nausea and vomiting requiring antiemetic treatment at registration.
3. Pregnant or nursing women, those who may become pregnant, or those not planning to use contraception.
4. Mental illness or psychiatric symptoms interfering with daily activities, making study participation difficult.
5. Diabetes treated with insulin/oral hypoglycemics or HbA1c (NGSP) ≥ 6.5% or HbA1c (JDS) ≥ 6.1% at registration.
6. Recent (within 6 months) unstable angina, myocardial infarction, cerebral hemorrhage, cerebral infarction, or active gastroduodenal ulcer.
7. Convulsive disorders requiring anticonvulsants, ascites needing therapeutic puncture, or gastrointestinal obstruction.
8. Inability to be hospitalized for up to 120 hours (Day 6) post-AC administration initiation.
9. Any other conditions deemed inappropriate for study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triple group	Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen	A three-drug antiemetic regimen with fosaprepitant, tropisetron, and olanzapine (triple group)
Quadruple group	Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen	A four-drug regimen including fosaprepitant, tropisetron, olanzapine, and dexamethasone (quadruple group)

Primary Outcome Measures

Name	Time	Method
Complete response rate (CR) during overall (0-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase.	0-120 hours after the initiation of anthracycline/cyclophosphamide administration	CR was determined by the absence of any retching or vomiting and the absence of any requirement for additional antiemetic treatment.

Secondary Outcome Measures

Name	Time	Method
Safety outcomes	Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration	Adverse event incidence rate
Quality of life based on Functional Living Index-Emesis (FLIE) assessment	0-120 hours after the initiation of anthracycline/cyclophosphamide administration	Quality of life based on Functional Living Index-Emesis (FLIE) assessment in the overall phase (0-120 h).
Exploratory endpoints-The time to the treatment failure	0-120 hours after the initiation of anthracycline/cyclophosphamide administration	The time to the treatment failure (time to first emetic episode or time to first use of rescue medication, whichever occurred first).
CR during the acute (0-24 hours after the initiation of anthracycline/cyclophosphamide administration) and delayed (24-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase	0-24 hours and 24-120 hours after the initiation of anthracycline/cyclophosphamide administration	CR was determined by the absence of any retching or vomiting and the absence of any requirement for additional antiemetic treatment.
Complete control rate (CC) during the acute, delayed, and overall phase	Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration	CC is defined as a condition in which a patient does not report more than mild nausea (0 or 1 on a 4-grade categorical scale) (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea).
Total control rate (TC) during the acute, delayed, and overall phases	Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration	TC is defined as a condition in which a patient does not report any nausea (0 on a 4-grade categorical scale) (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea).

Trial Locations

Locations (2)

Henan cancer hospital; 🇨🇳 Zhengzhou, Henan, China

Henan cacer hospital; 🇨🇳 Henan, Henan, China