Cancer pain
Conditions
Interventions
Hydromorphone Hydrochloride Sustained-release Tablets+denosumab:Hydromorphone Hydrochloride Sustained-release Tablets
Oxycodone sustained-release tablets+denosumab:Oxycodone sustained-release tablets
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with solid tumors diagnosed through histology or cytology, and confirmed bone metastases by imaging; 2. Age between 18 and 75 years; 3. Pain Numeric Rating Scale (NRS) score >= 4, with pain primarily caused by bone metastases; 4. At least 3 sites of bone metastases; 5. Expected survival period >= 3 months. 6. Liver and kidney function basically normal (serum creatinine clearance rate >= 30ml/min, total bilirubin <= 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase <= 3 times the upper limit of normal); 7. Able to take medication orally; 8. Patient has signed a consent form.
Exclusion criteria
Exclusion criteria: 1. Those allergic to hydromorphone, oxycodone extended-release tablets, or datopotamab; 2. Currently receiving treatment with other experimental drugs or have used other potent opioids during the designated washout period (if the washout period is less than 7 days); 3. Patients who have received cementation treatment, radiotherapy, chemotherapy, or other pain-related treatments within 7 days prior to the study; 4. Individuals with severe mental illness or cognitive impairment that prevents cooperation in the study evaluation; 5. Patients with severe cardiopulmonary dysfunction (New York Heart Association functional classification IV or uncorrectable respiratory failure); 6. Presence of other serious comorbidities or infections that may affect study results or increase treatment risks; 7. Other conditions deemed inappropriate for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reaction incidence rate;Pain relief rate after 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time required for pain relief to reach an NRS score of = 3 points;Changes in pain NRS scores at different time points;The improvement of patients' quality of life;Incidence of bone related events (SREs);Patient pharmacoeconomic evaluation;Biomarkers of bone metastasis cancer; | — |
Countries
China
Contacts
Public ContactLiu Zhenhua
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed