Moderate to severe cancer pain
Conditions
Interventions
The Experimental Group:The experimental group receives hydromorphone extended-release tablets at a starting dose of 8 mg orally once every 24 hours
as-needed immediate-release opioids are provided for breakthrough pain. During the study, the physician may adjust the dosage based on the patient's pain control and adverse reactions, and the reasons
The Control Group:The control group receives oxycodone extended-release tablets at a starting dose of 10–20 mg orally every 12 hours
Sponsors
Quanzhou First Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically or cytologically confirmed diagnosis of a malignant solid tumor accompanied by moderate to severe cancer pain; 2. According to the investigator's judgment, the patient currently requires initiation or continuation of strong opioid therapy as specified in the third step of the WHO three-step analgesic ladder for cancer pain; 3. NRS score >= 4; 4. Karnofsky Performance Status (KPS) score >= 50 and an expected survival of more than 3 months; 5. Adequate communication and comprehension skills, and the ability to understand and independently complete the 8-item Morisky Medication Adherence Scale (MMAS-8), the Numerical Rating Scale (NRS), the EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), and other similar scales; 6. Voluntary participation in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Presence of contraindications to the use of strong opioids; 2.Severe hepatic impairment (Child-Pugh Class C), severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m²); 3.Refractory cancer pain (after standardized medication for more than one week, pain remains moderate to severe or severe adverse reactions occur); 4.Presence of severe mental illness or cognitive impairment; 5.Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 8-item Morisky Medication Adherence Scale;Proportion of Days Covered; | — |
Secondary
| Measure | Time frame |
|---|---|
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30;Karnofsky Performance Status score;Adverse Reactions;Pain control compliance rate (NRS<=3); | — |
Countries
China
Contacts
Public ContactWang Yixiong
Quanzhou First Hospital Affiliated to Fujian Medical University
Outcome results
None listed