Lung cancer, liver cancer, stomach cancer, colorectal cancer, and neuropathic pain
Conditions
Interventions
Experimental group:oxycodone/naloxone prolonged-release tablets combined with crisugabalin
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 or older, any gender; 2. Weight over 45kg; 3. Patients with malignant tumors and clear pathological evidence of neuropathic pain (DN4 >=4); 4. Performance Status (PS) score: 0-3; 5. Moderate to severe cancer pain (NRS >=4); 6. Hospitalized patients with an expected survival of more than 3 months; 7. Not currently undergoing radiotherapy or pain located outside the radiation area; 8. Willing to participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Contraindications for Oxycodone-Naloxone Extended-Release Tablets (including allergy to the active ingredient or any excipients; severe respiratory depression with hypoxemia and/or hypercapnia; severe chronic obstructive pulmonary disease; cor pulmonale; severe bronchial asthma; paralytic ileus not caused by opioids; moderate to severe liver dysfunction). Subjects whose pain is related to tumor emergencies such as bowel obstruction/perforation, weight-bearing bone fractures, or impending fractures; 2. Patients with a history of autoimmune disease or severe infection; 3. History of drug abuse, illicit drug use, or heavy alcohol consumption; 4. History of dependence on psychiatric medications; 5. Allergy to opioids; 6. Patients with chronic obstructive or other lung diseases; 7. Those with brain trauma or increased intracranial pressure; 8. Patients with bradycardic heart disease; 9. Liver dysfunction (ALT >= 5×ULN, AST >= 5×ULN, TBIL >= 3×ULN), renal dysfunction (Cr >= 2.5×ULN), except for patients with primary liver or kidney tumors; 10. Pregnant or breastfeeding women; 11. Any situation that the researcher considers unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in NRS and DN4 scores at Week 4, as well as the pain response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of breakthrough pain (record the number of breakthrough pain episodes in 24 hours and the types and amounts of rescue medication used in 24 hours);The patient's improvement in bowel function (assessed using the Bowel Function Index, BFI);Sleep improvement situation (Pittsburgh Sleep Quality Index (PSQI));Improvement in quality of life (Quality of Life Questionnaire for Cancer Patients (EORTC QLQ-C30)); | — |
Countries
China
Contacts
Public ContactChengsong Cao
Xuzhou Central Hospital
Outcome results
None listed