Cancer Dyspnea Relief Trial
- Conditions
- Dyspnea in cancer patient
- Registration Number
- JPRN-UMIN000005760
- Lead Sponsor
- Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
(1) anemia is a cause of dyspnea (2) acute respiratory failure (3) decompensated heart failure (4) impairment of liver function: 5 times higher than upper normal value of AST or ALT, or total bilirubin > 2mg/dl (5) renal insufficiency : twice higher than upper normal value of Cr (6) bacterial enteritis (7) unstable pain: more than 5 in NRS(0-10) and plan to increase opioid within next 24hr (8) expected prognosis is less than 1 month (9) hypersensitivity to opium alkaloid (10) opioid rescue use for pain within 9 hour before taking investigational drug (11) opioid analgesic use for any symptoms other than pain within 24 hour before taking investigational drug (12) history of taking opioid rescue for dyspnea (13) prescribed codein, morphine, fentanyl, tramadol, or buprenorphine as regular medication (14) those who is considered not to be qualified for this trial by primary responsible doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mean change in intensity of dyspnea evaluated by NRS at 60 minutes after taking investigational drug in each group.
- Secondary Outcome Measures
Name Time Method (1) mean change in intensity of dyspnea evaluated by NRS at 120 minutes after taking investigational drug in each group. (2)the rate of the patietnts with more than 1 reduction in dyspnea intensity evaluated by NRS at 60 and 120 minutes after taking investigational drug in each group.