Unique ID issued by UMIN | UMIN000029556 |
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Receipt number | R000033731 |
Scientific Title | A Multicenter Randomized Open-label Trial Evaluating the Preventive Effect of Carbocisteine for Respiratory Tract Infection Induced by Chemotherapy in Japanese Non-Small Cell Lung Cancer Patients |
Date of disclosure of the study information | 2017/10/15 |
Last modified on | 2022/10/18 19:48:27 |
A Multicenter Randomized Open-label Trial Evaluating the Preventive Effect of Carbocisteine for Respiratory Tract Infection Induced by Chemotherapy in Japanese Non-Small Cell Lung Cancer Patients
JACC-R Study
A Multicenter Randomized Open-label Trial Evaluating the Preventive Effect of Carbocisteine for Respiratory Tract Infection Induced by Chemotherapy in Japanese Non-Small Cell Lung Cancer Patients
JACC-R Study
Japan |
Non-Small Cell Lung Cancer Patients
Pneumology | Chest surgery |
Malignancy
NO
Evaluating the efficacy of carbocisteine for respiratory tract infection induced by chemotherapy
Efficacy
Confirmatory
Pragmatic
Not applicable
Frequency of respiratory tract infection, influenza infection and febrile neutropenia at 6 months after the start of administration
Relative dose intensity of chemotherapy, Progression-free survival, Disease control rate, Peak flow and Safety at 6 months after the start of administration
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
No treatment
YES
NO
Institution is not considered as adjustment factor.
Numbered container method
2
Prevention
Medicine |
Administration of carbocisteine 500mg three times a day for 6 months
Usual care
20 | years-old | <= |
85 | years-old | >= |
Male and Female
Lung cancer patients who receive Platinum-Based Doublet or Platinum-Based Triplet regimen as 1st line therapy
Patients falling under contraindications of carbocysteine administration and being carbocysteine administered continuously before the beginning of chemotherapy
400
1st name | |
Middle name | |
Last name | KONAKA CHIMORI |
International University of Health and Welfare Ichikawa Hospital
Department of Respiratory Surgery
6-1-14 Kounodai, Ichikawa-shi, Chiba 272-0827, Japan
047-375-1111
yo.0519.hei@gmail.com
1st name | |
Middle name | |
Last name | YOHEI IIMURA |
International University of Health and Welfare Ichikawa Hospital
Department of Pharmacy
6-1-14 Kounodai, Ichikawa-shi, Chiba 272-0827, Japan
047-375-1111
yo.0519.hei@gmail.com
International University of Health and Welfare Ichikawa Hospital
International University of Health and Welfare Ichikawa Hospital / Self funding
Self funding
NO
2017 | Year | 10 | Month | 15 | Day |
Unpublished
Terminated
2017 | Year | 09 | Month | 20 | Day |
2017 | Year | 09 | Month | 30 | Day |
2017 | Year | 11 | Month | 01 | Day |
2020 | Year | 10 | Month | 01 | Day |
2017 | Year | 10 | Month | 15 | Day |
2022 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033731
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