Cancer pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) age 18-75 years old; 2) diagnosis of refractory cancer pain; 3) hospitalized patients; 4) male or female; 5) expected survival period of more than 2 months; 6) clear consciousness, no intellectual and mental impairment, normal language expression ability, Karnofsky performance score (KPS score) =50 points; 7) agreement to participate and a signed informed consent form.; 8) High-dose opioids used (greater than or equal to 300 mg/day of oral morphine(oral morphine equivalents, OME)) with poor pain control as NRS = 4 points or BTP= 3 times/day, or side-effects caused by opioids cannot be tolerated.
Exclusion criteria
Exclusion criteria: 1) cannot take drugs orally, such as intestinal obstruction, gastric retention, inability to swallow; 2) develop pain related to tumor emergencies, such as pathological fractures; 3) have mental illness or severe cognitive impairment; 4) are pregnant or lactating women; 5) have respiratory depression; 6) have a history of organic heart disease or arrhythmia; 7) have diagnosis of the active cerebrovascular disease; 8) are taking strong CYP3A4 inhibitors such as macrolide antibiotics, ketoconazole, itraconazole, voriconazole, and indinavir; 9) have a longer than 450 ms of QTc interval on the baseline electrocardiogram.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion success rate;Time to pain relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity;Breakthrough pain;methadone daily dose ;actual methadone conversion ratio;QTc interval ;Assessment of symptoms; | — |
Countries
China
Contacts
Zhejiang Cancer Hospital