Cancer Pain
Conditions
Interventions
Group A: Hydromorphone Extended Release Tablets+Proportionally Released Morphine for Relieving Burst Pain:Hydromorphone Extended Release Tablets+Proportionally Released Morphine for Relieving Burst Pa
Group B: Hydromorphone sustained-release tablets+fixed dose immediate release morphine to relieve burst pain:Hydromorphone sustained-release tablets+fixed dose immediate release morphine to relieve bu
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) aged 18-80 years old; 2) patients with successful IPCA titration of hydromorphone on day 0 and expected to receive more than 8mg/d of hydromorphone sustained-release tablets on day 1; 3) patients with pathologically confirmed malignant solid tumors; 4) patients with persistent cancer pain and NRS (0-10) >=7 in the past 24 hours; 5) patients requiring chemotherapy, long-term hormonal therapy, targeted therapy, or bisphosphonate therapy were receiving stable antineoplastic therapy before randomization that was deemed by the investigator to have no significant effect on pain intensity; 6) patients who have not received a trial drug within 14 days before the trial; 7) the patient had no cognitive impairment or psychiatric disorders; 8) Patients can complete the survey form, correctly understand and cooperate with the medication guidance of medical staff; 9) ECOG-PS<=3; 10) Subjects voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1) patients diagnosed with non-cancer pain or unexplained pain; 2) postoperative pain; 3) there were contraindications to the trial drug, such as patients with paralytic intestinal obstruction, chronic obstructive respiratory disease, pulmonary heart disease; 4) opioid allergy/addiction; 5) abnormal and clinically significant laboratory results, such as creatinine >= 2 times the upper limit of normal, ALT or AST>=2.5 times the upper limit of normal (>= 5 times the upper limit of normal in patients with liver metastases or primary liver cancer), or ChildC grade liver function; 6) patients who cannot take oral medication; 7) uncontrollable nausea and vomiting; 8) patients who received pain-related treatments such as radiotherapy or radionuclide therapy at the pain site within 7 days before randomization and trial; 9) pregnant or lactating women, those who plan to become pregnant within 1 month after the trial (also male subjects); 10) other diseases and conditions considered by the investigator to be ineligible for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average pain score on days 4-6; | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily average pain score for D1-6 days;Daily most severe pain score from D1 to 6 days;The proportion of patients with an average pain score of <= 4 on days 1-6;The proportion of patients who do not need to adjust their medication dosage after D3 and D6 days;The duration required for a 30% reduction in pain score compared to the baseline period (D-1);Compared to the baseline period (D-1), the time required for the average NRS to decrease to <= 4;Daily opioid dosage;Daily frequency and duration of pain outbreaks;Patient satisfaction with pain control;Patient Quality of Life; | — |
Countries
China
Contacts
Public ContactRongbo Lin
Fujian Cancer Hospital
Outcome results
None listed