Clinical trial NCT02364804: A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy for Non-small Cell Lung Cancer
Official title: A Study to Evaluate the Efficacy of Anti-emetic Drug Aprepitant Upon the Combination Chemotherapy of Nedaplatin and Docetaxel for Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Shiga University
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer patients who receive the combination chemotherapy of nedaplatin and docetaxel

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting
timeFrame: Fifteen days after beginning of each cycle of chemotherapy
Secondary outcomes:
measure: Influence on clinical outcome: Survival
timeFrame: Participants will be followed for 3 years after the last treatment
Other outcomes:
Locations:
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
Study officials:
affiliation: Shiga University of Medical Science
name: Yataro Daigo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: