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Completed

NCT Number: NCT02364804

A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy 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).

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Key information

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Emend

Primary outcomes

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

    Time frame: Fifteen days after beginning of each cycle of chemotherapy

Secondary outcomes

  1. Influence on clinical outcome: Survival

    Time frame: Participants will be followed for 3 years after the last treatment

Sponsors and collaborators

Lead sponsor

Shiga University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2015
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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