Non-small Cell Lung Cancer
Conditions
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.
Interventions
DRUGAprepitant
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 but Aprepitant.
Sponsors
Shiga University
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting | Fifteen days after beginning of each cycle of chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Influence on clinical outcome: Survival | Participants will be followed for 3 years after the last treatment |
Countries
Japan
Outcome results
None listed