Anti-emetic Prophylaxis With or Without Dexamethasone

Last updated: October 8, 2024
Sponsor: Henan Cancer Hospital
Overall Status: Completed

Phase

3

Condition

Stomach Discomfort

Colic

Lactose Intolerance

Treatment

Fosaprepitant , Tropisetron and Olanzapine

Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen

Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen

Clinical Study ID

NCT05242874
HELEN-009
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Breast cancer patients receiving their first anthracycline/cyclophosphamide-basedHEC regimen (cyclophosphamide 600 mg/m², epirubicin 90-100 mg/m²); divided dosesexcluded.

  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, WBCcount≥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 myocardialinfarction 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 duringtreatment.

  14. Informed consent obtained.

Exclusion

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 touse contraception.

  4. Mental illness or psychiatric symptoms interfering with daily activities, makingstudy 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, cerebralhemorrhage, cerebral infarction, or active gastroduodenal ulcer.

  7. Convulsive disorders requiring anticonvulsants, ascites needing therapeuticpuncture, or gastrointestinal obstruction.

  8. Inability to be hospitalized for up to 120 hours (Day 6) post-AC administrationinitiation.

  9. Any other conditions deemed inappropriate for study participation.

Study Design

Total Participants: 442
Treatment Group(s): 4
Primary Treatment: Fosaprepitant , Tropisetron and Olanzapine
Phase: 3
Study Start date:
February 01, 2022
Estimated Completion Date:
August 15, 2023

Study 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.

Connect with a study center

  • Henan cacer hospital

    Henan, Henan 450008
    China

    Site Not Available

  • Henan cancer hospital

    Zhengzhou, Henan
    China

    Site Not Available

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