Severe cancer pain
Conditions
Interventions
hydromorphone group:PCA settings for titration: Mix 10mg (10ml) of hydromorphone with 90ml of saline, to prepare the PCA pump (C=0.1mg/ml)
set con=0.1mg/h(1ml/h),bolus=0.2mg/(2ml/), lockout interval=10min.
The participants will press the bolus button at will, to meet the NRS of pain 3 OR breakthrough pain episodes >2/day OR the current d
morphine group:PCA settings for titration: Mix 50mg (5ml) of hydromorphone with 95ml of saline, to prepare the PCA pump (C=0.5mg/ml)
set con=0.5mg/h(1ml/h),bolus=1mg/(2ml), lockout interval=10min
The participants will press the bolus button at will, to meet the NRS of pain <=3 target in two 10-min interval evaluations.
For opioid-
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects voluntarily participate and sign the informed consent form for this trial; Patients with histologically or pathologically confirmed malignant tumors; Aged 18–80 years, mentally clear, regardless of gender; Patients with persistent cancer pain and an NRS (0–10) score of >=7 within the past 24 hours; Patients who have not undergone radiotherapy or chemotherapy within 2 weeks before randomization and the trial; Patients on long-term hormone therapy, targeted therapy, or bisphosphonate treatment must have been on stable anticancer therapy before randomization; Patients must have no cognitive impairment or psychiatric disorders; Patients must be able to correctly understand and comply with medication instructions from healthcare providers; ECOG Performance Status (ECOG-PS) <=3.
Exclusion criteria
Exclusion criteria: Patients diagnosed with non-cancer pain or pain of unknown origin; Patients with brain metastases accompanied by neurological symptoms; Patients with contraindications to the study drugs, such as paralytic ileus, chronic obstructive respiratory disease, cor pulmonale, etc.; Patients with refractory cancer pain (e.g., severe neuropathic cancer pain); Abnormal and clinically significant laboratory findings, including: Serum creatinine >=2× upper limit of normal (ULN); ALT or AST >=2.5× ULN (>=5× ULN for patients with liver metastases or primary hepatocellular carcinoma); Child-Pugh Class C liver function; Severe cognitive impairment; Pregnant or lactating patients; Patients with known hypersensitivity to the study drugs; Patients unable to take oral medications; Participation in another drug trial (including the investigational drug in this study) within 1 month prior to screening; Any other medical conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average episodes of daily breakthrough pain, from D1 to D6.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average daily NRS of pain, from D1 to D6.;PCA titration time till success;Overall satisfaction degree of pain control;Quality of life evaluation; | — |
Countries
China
Contacts
Public ContactDong-Ying Liu
Tianjin Medical University Cancer Institute & Hospital (TMUCIH)
Outcome results
None listed