Trial reportInvestigational new drugs2020
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.
Trial report in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02336750 (A Phase III Trial Comparing Dexamethasone, Aprepitant With or Without Mirtazapine in Delayed Emesis Control and Appetite Improvement), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III Trial Comparing Dexamethasone, Aprepitant With or Without Mirtazapine in Delayed Emesis Control and Appetite Improvement
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.
- 2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting.ESMO open · 2024Guideline
- 2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agents.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Pooled it
- Trial
- Global inequitable distribution of seminal studies of chemotherapy-induced nausea and vomiting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Review
- Mirtazapine revisited: new therapeutic perspectives and formulation advances.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Antidepressants and Weight Gain: An Update on the Evidence and Clinical Implications.Current obesity reports · 2025Review
- Novel therapies for nausea and vomiting in advanced illness and supportive cancer care.Palliative care and social practice · 2024Review
- Chemotherapy: how to reduce its adverse effects while maintaining the potency?Medical oncology (Northwood, London, England) · 2023Review
- Appetite Stimulant and Anti-Emetic Effect of Mirtazapine Transdermal Ointment in Cats Affected by Lymphoma Following Chemotherapy Administration: A Multi-Centre Retrospective Study.Animals : an open access journal from MDPI · 2022Article
- The Management of Nausea and Vomiting Not Related to Anticancer Therapy in Patients with Cancer.Current treatment options in oncology · 2021Review
- Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Anthracycline-cyclophosphamide Chemotherapy Regimen in Patients with Breast Cancer.Iranian journal of pharmaceutical research : IJPR · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background We examined the efficacy of mirtazapine in preventing delayed nausea and vomiting following highly emetogenic chemotherapy (HEC). Patients and methods Patients who had experienced delayed emesis and would be subsequently scheduled for at least three more cycles of the same chemotherapy were randomly assigned to either a mirtazapine (15 mg daily on days 2-4) or a control group. In addition, both groups received a standard triplet regimen comprising aprepitant, a 5-HT3 receptor antagonist, and dexamethasone (7.5 mg on days 2-4). The chemotherapy regimens were either an epirubicin plus cyclophosphamide regimen or cisplatin-containing regimens. The primary end point was a complete response (no emesis and no rescue treatment) to the delayed phase (25-120 h post-chemotherapy) during Cycle 1. The impact on quality of life (QOL) was assessed using the Functional Living Index-Emesis (FLIE) questionnaire. Results Of 95 enrolled patients, 46 were assigned to the mirtazapine group and 49 to the control group. The complete response rate in the delayed phase during Cycle 1 was significantly higher with mirtazapine than in the control group (78.3% versus 49.0%, P = 0.003). The main adverse effects of mirtazapine were mild to moderate somnolence and weight gain. Mean total FLIE scores were similar between the two arms. Conclusions This is the first randomized prospective study to show that adding mirtazapine has a substantial and statistically significant benefit with good tolerance in patients with breast cancer who have experienced delayed emesis following the same prior HEC. (Trial registration: ClinicalTrials.gov NCT02336750).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.