Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis

NCT ID: NCT02336750

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-12-31

Brief Summary

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

treatment group

D1:Chemotherapy Dexamethasone:7.5mg D2-4 Aprepitant:125mg D1, 80mg D2-3 Mirtazapine:15mg D2-4

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

125mg D1, 80mg D2-3

Mirtazapine

Intervention Type: DRUG

15mg D2-4

control group

D1:Chemotherapy Dexamethasone:7.5mg D2-4 Aprepitant:125mg D1, 80mg D2-3

Group Type: EXPERIMENTAL

Aprepitant

Intervention Type: DRUG

125mg D1, 80mg D2-3

Interventions

Aprepitant

125mg D1, 80mg D2-3

Intervention Type: DRUG

Mirtazapine

15mg D2-4

Intervention Type: DRUG

Other Intervention Names

Aprepitant Capsules; Mirtazapine Tablets

Eligibility Criteria

Inclusion Criteria

1. Patients who had delayed emesis after receiving AC regimen or regimens including cisplatin, and will subsequently accept the same chemotherapy regimens

2. Karnofsky Performance Status ≥60.

3. Life expectancy of more than 3 months.

4. 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

5. Be able to read, understand and complete the questionnaire and diary, including FLIE and Food Diary. Note: Must be able to understand written Chinese.

6. Be able to understand the study procedures and sign informed consent.

7. Meet one of the followings about contraception:

For fertile women：

1. 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.

2. 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.

3. 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:

1. Natural menopausal (natural menopausal ≥6 months and the serum FSH in the Postmenopausal range, or natural menopausal ≥12 months and age >45)

2. Bilateral tubal ligation

3. 6 weeks after the bilateral oophorectomy (with or without hysterectomy )

Exclusion Criteria

1. Treatment with any other study medicine within 4 weeks before enrollment and with unrecovered toxicities.

2. Women of reproductive age (including gestation period, lactation, a desire of pregnancy, oral contraceptives only)

3. Severe visceral disease: such as history of myocardial infarction or serious epilepsy needing medicine.

4. Mental disabilities or emotional or mental disorders.

5. Another malignancy within 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma).

6. 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.

7. Receiving any dose of systemic glucocorticoid treatment, but local or inhaled corticosteroids is allowed.

8. 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.

9. Having vomiting, retching or nausea within 24 hours before cisplatin treatment on the first day of the study.

10. Patient will receive abdominal or pelvic radiation between a week before and 6 days after the initiation of the study.

11. Prior aprepitant treatment or hypersensitivity history to any components of the study drug.

12. Cannot swallow capsules.

13. Not eligible for the study based on the investigators.

14. Patients receiving strong inducers of CYP3A4, such as carbamazepine, dipheninum, phenobarbitone, etc..

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xichun Hu

Vice Director of department of medical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xichun Hu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32036491 (View on PubMed)

Other Identifiers

Fudan BR2014-15 CBCSG019

Identifier Type: -

Identifier Source: org_study_id