Dyspnea associated with Cancer
Conditions
Interventions
THAM infusion at a rate of 0.2ml/kg/min for 20 min or 40 min
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I. The first stage 1) Age >= 20 2) Notified cancer patients 3) The patients having cancer dyspnea mainly caused by one of the following conditions: pleural effusion, ascites, primary lung tumor, metastatic lung tumor, cough, air way stenosis, and phrenic nerve paralysis, with or without chronic obstructive lung disease II. The second stage 1) Written informed consent 2) The patients with the sensation of dyspnea, the worst score of which is 6 or more on NRS, on 2 consecutive days 3) Expected survival of more than 2 weeks 4) The patients with the sensation of dyspnea after the treatment of rapid onset oral morphine 5) PS(ECOG)1-3 6) Hospitalized patients 7) Eligible for the first stage inclusion criteria
Exclusion criteria
Exclusion criteria: I. The first stage 1) Hypersensitivity reactions to THAM and opioids 2) Severe heart failure, respiratory disease with unstable dyspnea 3) Neurological, mental impairment with the difficulty of collecting data 4) Drug abuse, drug dependence 5) Pregnancy, lactation II. The second stage 1) Inability to take oral rapid onset morphine 2) Pain score above 3 3) Severe hypertention(SBP >= 180mmHg or DBP >= 110mmHg) 4) Liver failure, renal failure AST(GOT) >= 100IU/L ALT(GPT) >= 100IU/L T.bil >= 2.0mg/dL eGFR <= 30 mL/hr 5) Metabolic or respiratory acidosis 6) Severe respiratory failure or the administration of oxygen with flow rate of 10L/min or more 7) Ineligible condition for study in physician's judge 8) The change in prescription of opioids, steroids and anxiolytics within 2 days prior to study 9) The change in the chemotherapy within 7 days prior to study 10) SBP <= 90mmHg, SpO2 < 90%, RR at rest <= 10, BS < 60
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory depression, hypotention, hypoglycemia and adverse effects greater than grade 3 on CTCAE ver 4.0 | — |
Countries
Japan
Outcome results
None listed