Anti-emetic Prophylaxis With or Without Dexamethasone

October 8, 2024 updated by: Zhenzhen Liu, Henan Cancer Hospital

Anti-emetic Prophylaxis Using Fosaprepitant , Tropisetron, and Olanzapine, With or Without Dexamethasone for Anthracycline and Cyclophosphamide Chematherapy: A Multicenter, Randomized, Open-labeled Phase 3 Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
442

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Henan
      • Henan, Henan, China, 450008
        • Henan cacer hospital
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Triple group
A three-drug antiemetic regimen with fosaprepitant, tropisetron, and olanzapine (triple group)
Drug: Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen
Fosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4.
Other Names:
  • Fosaprepitant+Tropisetron+Olanzapine
Active Comparator: Quadruple group
A four-drug regimen including fosaprepitant, tropisetron, olanzapine, and dexamethasone (quadruple group)
Drug: Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen
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.
Other Names:
  • Fosaprepitant+Tropisetron+Olanzapine+Dexamethasone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete response rate (CR) during overall (0-120 hours after the initiation of anthracycline/cyclophosphamide administration) phase.
Time Frame: 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.
0-120 hours after the initiation of anthracycline/cyclophosphamide administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
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
Time Frame: 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).
Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Total control rate (TC) during the acute, delayed, and overall phases
Time Frame: 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).
Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Safety outcomes
Time Frame: Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Adverse event incidence rate
Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Quality of life based on Functional Living Index-Emesis (FLIE) assessment
Time Frame: 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).
0-120 hours after the initiation of anthracycline/cyclophosphamide administration
Exploratory endpoints-The time to the treatment failure
Time Frame: 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).
0-120 hours after the initiation of anthracycline/cyclophosphamide administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan Cancer Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhenzhen Liu, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HELEN-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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