Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis

NCT02336750 | Completed Phase 3

• 1 other identifier: Fudan BR2014-15 CBCSG019
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing Dexamethasone, Aprepitant and Mirtazapine With Dexamethasone and Aprepitant in Delayed Emesis Control and Appetite Improvement

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Delayed emesis control (no vomiting and no rescue treatment during 25-120 hours after initiation of chemotherapy)

  6 days

Secondary Outcomes (8)

• To assess safety of treatment group and control group. (number of participants with adverse events)

  9 weeks

• To assess appetite improvement after adding Mirtazapine treatment by using Food Diary.

  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.

  24 hours

• To assess complete response (CR) rate during 0-120 hours after initiation of chemotherapy.

  120 hours

• no rescue antiemetic therapy in 0-24 hours, 0-120 hours and 25-120 hours after initiation of chemotherapy

  24 hours; 120 hours

Study Arms (2)

treatment group

EXPERIMENTAL

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

Drug: Aprepitant; Drug: Mirtazapine

control group

EXPERIMENTAL

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

Drug: Aprepitant

Interventions

Aprepitant DRUG

125mg D1, 80mg D2-3

Also known as: Aprepitant Capsules

control group; treatment group

Mirtazapine DRUG

15mg D2-4

Also known as: Mirtazapine Tablets

treatment group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• 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..

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 32036491 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Aprepitant; Mirtazapine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of department of medical oncology

Study Record Dates

• First Submitted: January 3, 2015
• First Posted: January 13, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CN (1)