Cancer Pain
Conditions
Interventions
Group H:D1-14:Patients will adhere to scheduled dosing of extended-release hydromorphone, with rescue medication for breakthrough pain and protocol-defined dose adjustments. Those who develop intolera
Group O:D1-14:Patients will adhere to scheduled dosing of oxycodone hydrochloride prolonged-release tablets, with rescue medication for breakthrough pain and protocol-defined dose adjustments. Those w
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. male or female , >= 60 years old; 2. Life expectancy >= 3 months; 3. Clear consciousness, normal cognitive and language abilities ; 4. Karnofsky Performance Status (KPS) of >= 50 points; 5. Patients or relatives signed informed consent form and cooperated with follow-up; 6. Definite pathological or cytological diagnosis of malignant tumor based on International Union Against Cancer (UICC) tumor diagnostic criteria,or imaging combined with specific tumor markers; 7. Patients with cancer-related pain who met the following two criteria: (1) Opioid-naive patients:The FDA identifies tolerance as receiving at least 25 mcg/h fentanyl patch, at least 60 mg of morphine daily, at least 30 mg of PO oxycodone daily, at least 8 mg of PO hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer; (2) With inadequate controlled pain(NRS>=4) or intolerable adverse effects from the current analgesics;
Exclusion criteria
Exclusion criteria: 1. Inability to orally administer medications due to conditions such as intestinal obstruction, gastric retention, or swallowing difficulties; 2. Non cancer related pain or pain of unknown cause; 3. Pain attributable to oncologic emergencies (such as gastrointestinal perforation, spinal cord compression, or pathologic fracture, e.g.); 4. Presence of mental illness or severe cognitive impairment; 5. Unstable oxygen saturation due to respiratory depression or decompensated chronic obstructive pulmonary disease (COPD) or cor pulmonale; 6. Prolonged QTc interval in baseline electrocardiograms (defined as > 450 ms in male or > 470 ms in female); 7. Any underlying cardiac condition (e.g., significant arrhythmia or organic heart disease with dysfunction) considered by the investigator as a contraindication; 8. Diagnosis of active cerebrovascular disease; 9. With moderate or severe hepatic/renal insufficiency: serum creatinine value >= 2 times ULN , or ALT/AST >= 2.5 times ULN ( >= 5 times ULN for patients with liver metastasis) or Child C level (liver function); 10. Refractory cancer pain: defined as moderate or severe pain (NRS >= 4 or >= 3 daily breakthrough episodes) attributed to malignancy or its treatment, with inadequate pain relief or intolerability adverse effects after 1-2 weeks of standardized pharmacologic management; 11. Known hypersensitivity to any study opioid (e.g., hydromorphone, oxycodone, morphine); 12. CYP3A4 inhibitors use within 14 days pre-randomization; 13. New anticancer therapy (radiation or antineoplastic drug) during the run-in period; 14. Participating in other clinical trials that affect the evaluation of the results of this study; 15. With other concomitant diseases may affect the study according to the investigator's judgment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity; | — |
Secondary
| Measure | Time frame |
|---|---|
| daily frequency of BTP;Assessment of AEs;Assessment of symptoms;Opioids conversion ratios;Patient Global Impression of Change scale;Drug Switching Rate; | — |
Countries
China
Contacts
Public ContactLiyan Gong
Zhejiang Cancer Hospital
Outcome results
None listed