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

• Sponsor: Shiga University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02364804
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 41
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	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 Design

• Study Type: Observational
• Anticipated Enrollment: 10 participants
• Observational Model: Case-Control
• Time Perspective: Other
• 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 Start Date: Apr 1, 2012
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Outcome Measures

Primary Outcome Measures

1. Evaluation of anti-emetic drug efficacy: Incidence and grade of nausea/vomiting [Fifteen days after beginning of each cycle of chemotherapy]

Secondary Outcome Measures

1. Influence on clinical outcome: Survival [Participants will be followed for 3 years after the last treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shiga University of Medical Science Hospital	Otsu	Shiga	Japan	520-2192

Sponsors and Collaborators

• Shiga University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yataro Daigo, Professor, Shiga University
• ClinicalTrials.gov Identifier: NCT02364804
• Other Study ID Numbers: 24-20
• First Posted: Feb 18, 2015
• Last Update Posted: Sep 1, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Aprepitant

Study Results

No Results Posted as of Sep 1, 2020