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A randomized, open label, controlled phase II/III study of comparing efficacy and safety of dexamethasone, aprepitant, palonosetron with/without mirtazapine in delayed vomiting in patients with non-small cell lung cancer

Effectiveness and safety of triple or quadruple antiemetic regimens for delayed vomiting in non-small cell lung cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025211
Enrollment
Unknown
Registered
2019-08-16
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Control group:dexamethasone, aprepitant, palonosetron
Experimental group:dexamethasone, aprepitant, palonosetron and mirtazapine

Sponsors

Hu'nan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Initial NSCLC patients receiving stage IIIB-IV chemotherapy receive carboplatin or cisplatin-based chemotherapy. Patients selected for this study must meet all the following criteria: age > 18 years; delayed vomiting after chemotherapy and subsequent chemotherapy; Karnofsky score (> 60); and life expectancy > 3 months. The main organ functions are normal, that is to say, the following criteria should be met: (1) blood routine examination criteria: HB > 90 g/L (no blood transfusion within 14 days); ANC > 1.5 *10^9/L; PLT > 75 *10^9/L; (2) biochemical examination should meet the following criteria: TBIL < 1.5 ULN (upper limit of normal value); ALT and AST < 3.0 ULN; if there is liver metastasis, ALT and AST < 3.0 ULN. AST was less than 5 ULN, serum Cr was less than 1 *ULN, and endogenous creatinine clearance rate was more than 60 ml/min (Cockcroft-Gault formula). Patients can read, understand and complete research questionnaires and logs, including the Nausea and Vomiting Questionnaire (FLIE) and dietary diary questions. Note: Patients must be able to understand written Chinese. The patient understands the research procedure and signs a written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients have been treated with research drugs outside the scope of this study for the past four weeks or during the study period, and the toxicity of recent treatment has not been eliminated. Pregnancy, breast-feeding women, women of childbearing age who want to be pregnant or who only use oral contraceptives. Patients suffer from important organ disorders or diseases, such as history of myocardial infarction, severe epilepsy requiring medication, etc. Patients with mental disabilities or severe emotional or mental disorders. There is a history of other malignant tumors within 5 years (excluding cured cervical or skin basal cell carcinomas).

Design outcomes

Primary

MeasureTime frame
complete response rate in acute phase;complete response rate in delay phase;

Countries

China

Contacts

Public ContactZhang Lemeng

Hu'nan Cancer Hospital

zhanglemeng@hnca.org.cn+86 18684689890

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026