Cancer Pain
Conditions
Interventions
Oxycodone:Original opioid analgesic drugs: oxycodone sustained-release tablets, the administered dose remains unchanged, and for morphine sustained-release tablets or fentanyl patches, the correspondi
Morphine:Original opioid analgesic drugs: oxycodone sustained-release tablets, the administered dose remains unchanged, and for morphine sustained-release tablets or fentanyl patches, the correspondi
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-75 years, male or female; 2. pathologically or cytologically confirmed malignant tumors; 3. cancer visceral pain caused by primary or secondary malignant tumors in the abdominal cavity and thoracic cavity, and pain numerical rating scale (NRS) = 7 points; 4. performance status score Karnofsky score (KPS) = 50 points 5. oral drug capacity; 6. expected survival = 1 month; 7. The subject voluntarily signs the informed consent form; 8. Subjects must understand the study process, be able to objectively describe symptoms, and follow the study plan and visit plan.
Exclusion criteria
Exclusion criteria: 1. language communication disorders; cognitive deficits or mental illness; or intracranial tumor metastasis and disturbance of consciousness; or other willing to cause disturbance of consciousness; 2. clinically significant laboratory abnormalities: creatinine values = 2 times the upper limit of normal or ALT/AST = 2.5 times the upper limit of normal (liver metastases can be relaxed to = 5 times the upper limit of normal) or liver function child C grade; 3. psychogenic pain; 4. the subject has a history of alcohol abuse, drug abuse and/or opioid abuse; 5. have a history of drug allergy similar to the structure of the study drug; 6. patients who are participating in other clinical studies that may affect opioid use or effect assessment; 7. During clinical observation, start to use new anti-tumor drugs or new radiotherapy regimens; 8. abdominal pain due to acute abdomen (such as gastrointestinal perforation) or obstructive/paralytic ileus; 9. pregnant or pregnant patients; 10. Patients with frequent diarrhea or nausea and vomiting caused by short bowel syndrome or other gastrointestinal diseases and poor control do not meet the inclusion criteria, or are considered unsuitable for this trial by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving "pain stabilization" during the study period (d3-6 days);Time to first pain relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of patients with successful pain control within 1 h, 24 h after PCA;Daily mean NRS score;Daily opioid dose;Number of daily breakthrough pain and highest NRS score for breakthrough pain;Number of patients transferred/discontinued due to serious adverse events or inadequate pain control;Patient Symptom Assessment;Patient satisfaction with pain control;Conversion Ratio of Intravenous and Oral Oxycodone in Patients Achieving Stable Pain; | — |
Countries
China
Contacts
Public ContactGong Liyan
Zhejiang Cancer Hospital
Outcome results
None listed