Breast CancerPhase 3NCT02336750
Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis
A Phase 3 study testing Aprepitant and Mirtazapine in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Aprepitant and Mirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had delayed emesis after receiving AC regimen or regimens including cisplatin, and will subsequently accept the same chemotherapy regimens
- Karnofsky Performance Status ≥60.
- Life expectancy of more than 3 months.
- Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases), Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>60ml/min
- Be able to read, understand and complete the questionnaire and diary, including FLIE and Food Diary. Note: Must be able to understand written Chinese.
- Be able to understand the study procedures and sign informed consent.
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- Meet one of the followings about contraception:
- For fertile women：
- Urine pregnancy test in screening should be negative. If urine pregnancy test is positive, the patient could be enrolled only when serum pregnancy test is negative.
- They should agree to abstinence or use double barrier methods of contraception during the research, within at least 14 days before enrolling and one month after the last dose of study medicine.
- If taking oral contraceptives, the patient should agree to add a barrier method of contraception during the research, within at least 14 days before enrolling and one month after the last dose of study medicine.
- Unfertility is defined as anyone of the followings:
- Natural menopausal (natural menopausal ≥6 months and the serum FSH in the Postmenopausal range, or natural menopausal ≥12 months and age >45)
- Bilateral tubal ligation
- 6 weeks after the bilateral oophorectomy (with or without hysterectomy )
Who cannot join
- Treatment with any other study medicine within 4 weeks before enrollment and with unrecovered toxicities.
- Women of reproductive age (including gestation period, lactation, a desire of pregnancy, oral contraceptives only)
- Severe visceral disease: such as history of myocardial infarction or serious epilepsy needing medicine.
- Mental disabilities or emotional or mental disorders.
- Another malignancy within 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma).
- Uncontrolled disease, such as active infections (pneumonia), diabetic ketoacidosis, gastrointestinal obstruction. And other cases which would cause bias or make patients exposed to unnecessary risks.
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- Receiving any dose of systemic glucocorticoid treatment, but local or inhaled corticosteroids is allowed.
- Benzodiazepines or opioids treatment within 48 hours before the first day of the study, except for a single daily taking of triazolam, temazepam or midazolam.
- a)Benzodiazepines or opioids given 48 hours or longer before the first day of the study are allowed and patients can continue the medication.
- Having vomiting, retching or nausea within 24 hours before cisplatin treatment on the first day of the study.
- Patient will receive abdominal or pelvic radiation between a week before and 6 days after the initiation of the study.
- Prior aprepitant treatment or hypersensitivity history to any components of the study drug.
- Cannot swallow capsules.
- Not eligible for the study based on the investigators.
- Patients receiving strong inducers of CYP3A4, such as carbamazepine, dipheninum, phenobarbitone, etc..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Trial Comparing Dexamethasone, Aprepitant With or Without Mirtazapine in Delayed Emesis Control and Appetite Improvement
Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement
Read the detailed description
A Phase III Trial Comparing Efficacy and Safety of Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement
- Conditions
- Breast Cancer
- Being tested
- Aprepitant, Mirtazapine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Aprepitant Capsules
125mg D1, 80mg D2-3
MirtazapineDrug
Also called Mirtazapine Tablets
15mg D2-4
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | D1:Chemotherapy Dexamethasone:7.5mg D2-4 Aprepitant:125mg D1, 80mg D2-3 Mirtazapine:15mg D2-4 Receives: Drug: Aprepitant; Drug: Mirtazapine |
| control group | Experimental | D1:Chemotherapy Dexamethasone:7.5mg D2-4 Aprepitant:125mg D1, 80mg D2-3 Receives: Drug: Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed emesis control (no vomiting and no rescue treatment during 25-120 hours after initiation of chemotherapy)
Measured: 6 days
Secondary outcomes (8)
To assess safety of treatment group and control group. (number of participants with adverse events)
Measured: 9 weeks
To assess appetite improvement after adding Mirtazapine treatment by using Food Diary.
Measured: 9 weeks
To assess complete response (CR) rate during 0-24 hours after initiation of chemotherapy, to examine differences in acute emesis control after adding Aprepitant treatment.
Measured: 24 hours
To assess complete response (CR) rate during 0-120 hours after initiation of chemotherapy.
Measured: 120 hours
no rescue antiemetic therapy in 0-24 hours, 0-120 hours and 25-120 hours after initiation of chemotherapy
Measured: 24 hours; 120 hours
time to first vomiting episode, time to first rescue antiemetic therapy and time to treatment failure (based on first vomiting episode or first rescue antiemetic therapy, whichever occurs first)
Measured: 9 weeks
To assess the impact on patients' daily life activities in both acute and delayed emesis phases after chemotherapy by using the Functional Living Index -Emesis (FLIE).
Measured: 120 hours
To assess impact of nausea and vomiting on compliance of patients receiving chemotherapy.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336750
- Sponsor's protocol ID
- Fudan BR2014-15 CBCSG019
- Status last verified
- Apr 2022
- First submitted
- 3 Jan 2015
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Cao J, Ouyang Q, Wang S, Ragaz J, Wang X, Teng Y, Wang B, Wang Z, Zhang J, Wang L, Wu J, Shao Z, Hu X. Mirtazapine, a dopamine receptor inhibitor, as a secondary prophylactic for delayed nausea and vomiting following highly emetogenic chemotherapy: an open label, randomized, multicenter phase III trial. Invest New Drugs. 2020 Apr;38(2):507-514. doi: 10.1007/s10637-020-00903-8. Epub 2020 Feb 8.
PubMed 32036491
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial Comparing Dexamethasone, Aprepitant With or Without Mirtazapine in Delayed Emesis Control and Appetite Improvement
- ClinicalTrials.gov ID
- NCT02336750
- Acronym / sponsor ID
- Fudan BR2014-15 CBCSG019
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 13 Jan 2015 (estimated)
- 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.
Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement
Detailed description
A Phase III Trial Comparing Efficacy and Safety of Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Aprepitant, Drug: MirtazapineD1:Chemotherapy Dexamethasone:7.5mg D2-4 Aprepitant:125mg D1, 80mg D2-3 Mirtazapine:15mg D2-4 |
| control group | Experimental | Drug: AprepitantD1:Chemotherapy Dexamethasone:7.5mg D2-4 Aprepitant:125mg D1, 80mg D2-3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients who had delayed emesis after receiving AC regimen or regimens including cisplatin, and will subsequently accept the same chemotherapy regimens
- Karnofsky Performance Status ≥60.
- Life expectancy of more than 3 months.
- Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases), Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>60ml/min
- Be able to read, understand and complete the questionnaire and diary, including FLIE and Food Diary. Note: Must be able to understand written Chinese.
Key exclusion criteria (15 listed)
- Treatment with any other study medicine within 4 weeks before enrollment and with unrecovered toxicities.
- Women of reproductive age (including gestation period, lactation, a desire of pregnancy, oral contraceptives only)
- Severe visceral disease: such as history of myocardial infarction or serious epilepsy needing medicine.
- Mental disabilities or emotional or mental disorders.
- Another malignancy within 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma).
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 |
|---|---|---|
| AprepitantAlso: Aprepitant Capsules125mg D1, 80mg D2-3 | Drug | control group, treatment group |
| MirtazapineAlso: Mirtazapine Tablets15mg D2-4 | Drug | treatment group |
Primary outcome
Delayed emesis control (no vomiting and no rescue treatment during 25-120 hours after initiation of chemotherapy)
Time frame: 6 days
8 secondary outcomes
To assess safety of treatment group and control group. (number of participants with adverse events)
Time frame: 9 weeks
To assess appetite improvement after adding Mirtazapine treatment by using Food Diary.
Time frame: 9 weeks
To assess complete response (CR) rate during 0-24 hours after initiation of chemotherapy, to examine differences in acute emesis control after adding Aprepitant treatment.
Time frame: 24 hours
To assess complete response (CR) rate during 0-120 hours after initiation of chemotherapy.
Time frame: 120 hours
no rescue antiemetic therapy in 0-24 hours, 0-120 hours and 25-120 hours after initiation of chemotherapy
Time frame: 24 hours; 120 hours
time to first vomiting episode, time to first rescue antiemetic therapy and time to treatment failure (based on first vomiting episode or first rescue antiemetic therapy, whichever occurs first)
Time frame: 9 weeks
To assess the impact on patients' daily life activities in both acute and delayed emesis phases after chemotherapy by using the Functional Living Index -Emesis (FLIE).
Time frame: 120 hours
To assess impact of nausea and vomiting on compliance of patients receiving chemotherapy.
Time frame: 9 weeks
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 20 Apr 2022.
- Derived from this study: PubMed 32036491Cao J, Ouyang Q, Wang S, Ragaz J, Wang X, Teng Y, Wang B, Wang Z, Zhang J, Wang L, Wu J, Shao Z, Hu X. Mirtazapine, a dopamine receptor inhibitor, as a secondary prophylactic for delayed nausea and vomiting following highly emetogenic chemotherapy: an open label, randomized, multicenter phase III trial. Invest New Drugs. 2020 Apr;38(2):507-514. doi: 10.1007/s10637-020-00903-8. Epub 2020 Feb 8.
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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.
Xichun Hu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprepitant and Mirtazapine in people with Breast Cancer, run by Fudan University at 1 site 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 15 inclusion and 15 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 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Delayed emesis control (no vomiting and no rescue treatment during 25-120 hours after initiation of chemotherapy) (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02336750, which also lists 1 linked publication.
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 20 Apr 2022.