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

NCT02364804 | Completed

• 1 other identifier: 24-20
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting

  Fifteen days after beginning of each cycle of chemotherapy

Secondary Outcomes (1)

• Influence on clinical outcome: Survival

  Participants will be followed for 3 years after the last treatment

Interventions

Aprepitant DRUG

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.

Also known as: Emend

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-small cell lung cancer patients who receive the combination chemotherapy of nedaplatin and docetaxel

You may qualify if:

• Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer.
• ECOG performance status 0-1.
• Aged 20-79 years old.
• 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.
• Able and willing to give valid written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Shiga University: lead

Study Sites (1)

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yataro Daigo, MD, PhD

  Shiga University of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 18, 2015
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

JP (1)