Chemotherapy-induced Nausea and VomitingPhase 3NCT05242874
Anti-emetic Prophylaxis With or Without Dexamethasone
A Phase 3 study testing Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen and Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen in people with Chemotherapy-induced Nausea and Vomiting, run by Henan Cancer Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen and Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2022to 15 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Henan cacer hospital
Henan, Henan, 450008
Henan cancer hospital
Zhengzhou, Henan
About this study
Official title: 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.
Read the 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen, Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen
- Keywords
- Nausea, Vomiting, Glucocorticoids, Olanzapine, Tropisetron, Fosaprepitant, Signs and Symptoms, Digestive, Antiemetics, Physiological Effects of Drugs
- Medical subject headings
- Vomiting, Nausea, Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimenDrug
Also called Fosaprepitant+Tropisetron+Olanzapine
Fosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4.
Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimenDrug
Also called Fosaprepitant+Tropisetron+Olanzapine+Dexamethasone
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.
| Study group | Role | What they receive |
|---|---|---|
| Triple group | Experimental | A three-drug antiemetic regimen with fosaprepitant, tropisetron, and olanzapine (triple group) Receives: Drug: Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen |
| Quadruple group | Active comparator | A four-drug regimen including fosaprepitant, tropisetron, olanzapine, and dexamethasone (quadruple group) Receives: Drug: Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
CR was determined by the absence of any retching or vomiting and the absence of any requirement for additional antiemetic treatment.
Measured: 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
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).
Measured: Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Total control rate (TC) during the acute, delayed, and overall phases
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).
Measured: Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Safety outcomes
Adverse event incidence rate
Measured: Day 1 to day 5 after the initiation of anthracycline/cyclophosphamide administration
Quality of life based on Functional Living Index-Emesis (FLIE) assessment
Quality of life based on Functional Living Index-Emesis (FLIE) assessment in the overall phase (0-120 h).
Measured: 0-120 hours after the initiation of anthracycline/cyclophosphamide administration
Exploratory endpoints-The time to the treatment failure
The time to the treatment failure (time to first emetic episode or time to first use of rescue medication, whichever occurred first).
Measured: 0-120 hours after the initiation of anthracycline/cyclophosphamide administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Feb 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242874
- Sponsor's protocol ID
- HELEN-009
- Status last verified
- Oct 2024
- First submitted
- 28 Jan 2022
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05242874
- Acronym / sponsor ID
- HELEN-009
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Nausea, Vomiting, Glucocorticoids, Olanzapine, Tropisetron, Fosaprepitant, Signs and Symptoms, Digestive, Antiemetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple group | Experimental | Drug: Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimenA three-drug antiemetic regimen with fosaprepitant, tropisetron, and olanzapine (triple group) |
| Quadruple group | Active comparator | Drug: Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimenA four-drug regimen including fosaprepitant, tropisetron, olanzapine, and dexamethasone (quadruple group) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimenAlso: Fosaprepitant+Tropisetron+OlanzapineFosaprepitant 150 mg intravenously on Day 1, tropisetron 5 mg intravenously on Day 1, and olanzapine 5 mg orally on Days 1 to 4. | Drug | Triple group |
| Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimenAlso: Fosaprepitant+Tropisetron+Olanzapine+DexamethasoneFosaprepitant 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. | Drug | Quadruple group |
Primary outcome
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.
6 secondary outcomes
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
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
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
Safety outcomes
Time frame: 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
Exploratory endpoints-The time to the treatment failure
Time frame: 0-120 hours after the initiation of anthracycline/cyclophosphamide administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenzhen Liu principal investigator
Henan Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fosaprepitant, tropisetron, and olanzapine-based antiemetic regimen and Fosaprepitant, tropisetron, olanzapine, and dexamethasone-based antiemetic regimen in people with Chemotherapy-induced Nausea and Vomiting, run by Henan Cancer Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.