Primary lung cancer
Conditions
Interventions
Inhalation of Tiotropium, 5 microgram once daily, starting from 2 weeks before the surgery.
No inhalation of Tiotropium. Other short acting anticholinergics or beta2-agonists are permissible.
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Clinically suspected primary lung cancer. 2) Postbronchodilator FEV1/FVC (forced expiratory volume in 1s/forced vital capacity) < 0.70 assessed by spirometry. 3) Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria I - II (FEV1 => 50% of predicted value). 4) Modified Medical Research Council (MRC) score =< 1. 5) Resectable cancer lesion by surgery less than single lobectomy. 6) Without previously treatment for chronic obstructive pulmonary disease (COPD), bronchial asthma. 7) No past pulmonary resection excluding wedge resection. 8) Patients stopping smoking at the time of giving the consent to this study. 9) Adequate organ function tolerable for the general anesthesia. 10) Capable of inhalation. 11) Age of 20 years or older. 12) ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-1. 13) Written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1) Median sternotomy. 2) Combined resection of the chest wall excluding parietal pleura excision. 3) History of active infection. 4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer. 5) Patients with glaucoma. 6) Patients with dysuria. 7) History of hypersensitivity to atropine or drugs similar to atropine. 8) Patients with interstitial pneumonia or pulmonary fibrosis. 9) Patients with arrhythmia requiring antiarrhythmic continuously. 10) Patients with thyropathy. 11) Patients with renal dysfunction needs blood purification therapy. 12) Patients with psychiatric disease. 13) Patients requiring systemic steroids medication. 14) Patients with uncontrolled diabetes mellitus. 15) Patients with uncontrolled hypertension. 16) Current or previous within the last 6 months history of severe heart diseases, cerebrovascular disease. 17) The pregnant and lactating female , female who has possibility of the pregnancy. 18) Patients who were judged inappropriate to entry this study by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of cardiopulmonary complications within 1 year after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Improvement of pulmonary function before and after inhalation of Tiotropium 2)Rate of post operative complications excluding cardiopulmonary complications 3)3-years overall survival 4)Rate of adverse events 5)Evaluation of postoperative compliance | — |
Countries
Japan
Contacts
Public ContactTeppei Nishii
Yokohama City University Medical Center Respiratory Disease Center
Outcome results
None listed