Cancer Pain
Conditions
Interventions
Normal people versus cases:none
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The age of male or female patients are 18 years old (no age limit); 2. Metastatic bone cancer patients, patients with advanced cancer confirmed by histology or cytology (mainly included in breast cancer and prostate cancer); 3. Pain, NRS 4 (24 h average); 4. Use opioids according to the pain (morphine, oxycontin, methoxycontin, fentanyl transdermal patch); 5. Patients should meet the following biochemical indicators: A. total bilirubin 1.5 upper limit of normal value (ULN) (total bilirubin level in patients with Gilbert syndrome must be less than 4 times the upper limit of normal value);B. AST and ALT<1.5 normal upper limit (ULN) (<5 times normal upper limit if related to liver metastasis); C. Serum creatinine <1.5 times the normal upper limit; D. Creatinine clearance 60ml/min; 6. KPS score 60 (ECOG<2); 7. Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. The expected survival time is less than 2 months; 2. The patient had a history of chronic renal insufficiency, and the creatinine clearance rate was 1.5 normal value (ULN) (upper limit of total bilirubin >4 times normal level in patients with Gilbert syndrome); (2) AST and ALT>1.5 normal upper limit (ULN) (5 times normal upper limit if related to liver metastasis); 4. Patients with pulmonary infection, lung tumor, interstitial pneumonia, patients who have received lung radiotherapy, and severe dyspnea or respiratory failure;Serious cardiovascular and cerebrovascular diseases: cardiac insufficiency, myocardial infarction, cerebrovascular accidents, etc.; 5. According to the evaluation of the researcher, the patients were not suitable for the enrollment, such as neuropathic pain, obvious spontaneous pain, opioid or other drug or drug abuse history, and alcoholism; 6. The patient is undergoing other trials to prohibit the combination therapy, and the medication cannot be stopped during the study; 7. The investigator believes that the patient's medical history or complications may affect the patient's ability to comply with the test or interfere with the evaluation of the safety of the test drugs; 8. Using opioids regularly every day; 9. Other conditions deemed inappropriate by the researcher for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory depression; | — |
Countries
China
Contacts
Public ContactBin Jiang
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine (North)
Outcome results
None listed