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

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

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).

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Aprepitant

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Japan
  • Shiga
    • Otsu, Shiga, Japan, 520-2192
      • Shiga University of Medical Science Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Influence on clinical outcome: Survival	Participants will be followed for 3 years after the last treatment

Collaborators and Investigators

• Sponsor: Shiga University
• Investigators: Principal Investigator: Yataro Daigo, MD, PhD, Shiga University of Medical Science

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Aprepitant
• Other Study ID Numbers: 24-20