Anti-emetic Prophylaxis With or Without Dexamethasone

NCT05242874 | Completed Phase 3

• 1 other identifier: HELEN-009
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 2

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Nausea; Vomiting; Glucocorticoids; Olanzapine; Tropisetron; Fosaprepitant; Signs and Symptoms, Digestive; Antiemetics; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (1)

• Complete response rate (CR) during overall (0-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase.

  CR was determined by the absence of any retching or vomiting and the absence of any requirement for additional antiemetic treatment.

  0-120 hours after the initiation of anthracycline/cyclophosphamide administration

Secondary Outcomes (6)

• 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

• Complete control rate (CC) during the acute, delayed, and overall phase

  Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration

• Total control rate (TC) during the acute, delayed, and overall phases

  Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration

• Safety outcomes

  Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration

• Quality of life based on Functional Living Index-Emesis (FLIE) assessment

  0-120 hours after the initiation of anthracycline/cyclophosphamide administration

Study Arms (2)

Triple group

EXPERIMENTAL

A three-drug antiemetic regimen with fosaprepitant, tropisetron, and olanzapine (triple group)

Drug: Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen

Quadruple group

ACTIVE COMPARATOR

A four-drug regimen including fosaprepitant, tropisetron, olanzapine, and dexamethasone (quadruple group)

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

Interventions

Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen DRUG

Fosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4.

Also known as: Fosaprepitant+Tropisetron+Olanzapine

Triple group

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

Fosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4. Dexamethasone 12 mg on Day 1, followed by 8 mg on Days 2 to 4.

Also known as: Fosaprepitant+Tropisetron+Olanzapine+Dexamethasone

Quadruple group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patients receiving their first anthracycline/cyclophosphamide-based HEC regimen (cyclophosphamide 600 mg/m², epirubicin 90-100 mg/m²); divided doses excluded.
• No prior chemotherapy.
• Aged 18-70 years.
• ECOG performance status 0 or 1.
• 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).
• No nausea or vomiting within 24 hours before registration.
• Negative pregnancy test within 7 days prior (women of childbearing potential).
• No severe cognitive impairment.
• No hypersensitivity to fosaprepitant, tropisetron, olanzapine, and dexamethasone.
• No significant cardiac issues: arrhythmia, recent heart failure, or myocardial infarction within 6 months.
• No symptomatic brain metastasis or carcinomatous meningitis.
• No diabetes requiring insulin or oral medication.
• No use of prohibited medications within 48 hours before registration or during treatment.
• Informed consent obtained.

You may not qualify if:

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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (2)

Henan cacer hospital

Henan, Henan, 450008, China

Location

Henan cancer hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Vomiting; Nausea; Signs and Symptoms, Digestive

Interventions

fosaprepitant; Tropisetron; Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines

Study Officials

• Zhenzhen Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Breast Oncology

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 16, 2022
• Study Start: February 1, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

CN (2)