A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy for Non-small Cell Lung Cancer

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT02364804
• Lead Sponsor: Shiga University

Brief Summary

The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).

Detailed Description

The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents except Aprepitant.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Primary Completion: 2015-03
• Study Completion: 2015-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-28
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer.
2. ECOG performance status 0-1.
3. Aged 20-79 years old.
4. Laboratory values as follows 4000/mm3 < WBC < 12000/mm3, neutrophil count > 2000/mm3, platelet count > 100000/mm3, hemoglobin > 9.5g/dL, asparate transaminase < 2.5 X cutoff value, alanine transaminase < 2.5 X cutoff value, total bilirubin < 1.5g/dL, Serum creatinine < cutoff value, PaO2 > 60 Torr.
5. Able and willing to give valid written informed consent.

Exclusion Criteria

1. Allergy against polysorbert 80 or platinum-containing drugs.
2. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency).
3. Active and uncontrolled infectious disease.
4. Massive pleural or pericardial effusion.
5. Other malignancy requiring treatment.
6. Active interstitial pneumonitis or its past historyBreastfeeding and Pregnancy (woman of child bearing potential)
7. Peripheral nerve disorder.
8. Pregnant or lactating women.
9. Concurrent administration of pimozide.
10. Decision of unsuitableness by principal investigator or physician-in-charge

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting	Fifteen days after beginning of each cycle of chemotherapy

Secondary Outcome Measures

Name	Time	Method
Influence on clinical outcome: Survival	Participants will be followed for 3 years after the last treatment

Trial Locations

Locations (1)

Shiga University of Medical Science Hospital; 🇯🇵 Otsu, Shiga, Japan