Unique ID issued by UMIN | UMIN000014361 |
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Receipt number | R000016701 |
Scientific Title | Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery |
Date of disclosure of the study information | 2014/06/25 |
Last modified on | 2020/12/28 10:52:44 |
Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Japan |
Primary lung cancer
Chest surgery |
Malignancy
NO
We will investigate the effect of Salmeterol on surgery for primary lung cancer in COPD patients.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Improvement of pulmonary function associated with inhalation of Salmeterol
1) Rate of postoperative complications
2) Self-assessment of respiratory insufficiency
3) 1-year overall survival
4) Rate of adverse events
5) Evaluation of postoperative compliance
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
NO
Central registration
2
Treatment
Medicine |
Inhalation of Salmeterol, 50 microgram twice daily, starting from 10 days before the surgery.
No inhalation of Salmeterol.
20 | years-old | <= |
Not applicable |
Male and Female
1)Clinically suspected or diagnosed primary lung cancer.
2)FEV1.0/FVC < 0.70, assessed by spirometry.
3)Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria I-III.
4)Modified Medical Research Council (MRC) score =<1.
5)Resectable cancer lesion by single lobectomy.
6)No previous treatment of COPD or asthma.
7)No past history of pulmonary resection.
8)Patients being able to stop smoking at the time of the registry to this trial.
9)Adequate organ function tolerable for the general anesthesia.
10)Capable for inhalation.
11)Age of 20 years or older.
12)ECOG performance status: 0, 1
13)Written informed consent to participate.
1)Median sternotomy.
2)Combined resection of the chest wall.
3)Active infection.
4)Active double cancer.
5)Current or previous history of severe heart diseases or cerebrovascular disases. Uncontrolled diabetes mellitus or hypertension. Interstitial pneumonia. Arrhythmia requiring antiarrhythmic continuously. Renal dysfunction necessitating blood purification therapy.
6)Patients with psychiatric disease.
7)Patients requiring systemic steroids medication.
8)Pregnant and lactating female, female who has possibility of pregnancy.
9)Past history of drug allergy.
10)Hypokalemia.
11)Patients who were judged inappropriate to enter this trial by physician.
120
1st name | |
Middle name | |
Last name | Taichiro Goto |
Yamanashi Prefectural Central Hospital
General Thoracic Surgery
1-1-1 Fujimi, Kofu-shi, Yamanashi 400-8506, Japan
055-253-7111
taichiro@1997.jukuin.keio.ac.jp
1st name | |
Middle name | |
Last name | Taichiro Goto |
Yamanashi Prefectural Central Hospital
General Thoracic Surgery
1-1-1 Fujimi, Kofu-shi, Yamanashi 400-8506, Japan
055-253-7111
taichiro@1997.jukuin.keio.ac.jp
Yamanashi Prefectural Central Hospital
None
Self funding
NO
2014 | Year | 06 | Month | 25 | Day |
Unpublished
Preinitiation
2014 | Year | 05 | Month | 21 | Day |
2014 | Year | 07 | Month | 01 | Day |
2020 | Year | 12 | Month | 31 | Day |
2014 | Year | 06 | Month | 24 | Day |
2020 | Year | 12 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016701
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