Cancer Pain
Conditions
Interventions
3DS Group:D1-3:The original opioid drugs were converted into methadone by 3DS
D4-14:the dosage of methadone was increased at least 5 days of observation according to the frequency of BTP, and short-acting opioids were supplemented as needed ,adverse reactions were treated
SAG-N Group:D1:The original opioid drugs were converted into methadone by 20:1
D2-14:the dosage of methadone was increased at least 5 days of observation according to the frequency of BTP, and short-acting opioids were supplemented as needed ,adverse reactions were treated
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old, male or female; (2) Life expectancy = 2 months; (3) Clear consciousness, normal cognitive and language abilities ,Karnofsky performance score (KPS) of = 50 points; (4) Patients or relatives signed informed consent form and cooperated with follow-up; (5) 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. (6) The pain is related to cancer. (7) On = 300 mg oral morphine equivalent daily dose (OMEDD) with refractory cancer pain as defined diagnosis of refractory cancer pain;
Exclusion criteria
Exclusion criteria: ?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)Presence of mental illness or severe cognitive impairment, (4)Pregnancy or lactation; (5)Respiratory depression; (6)Concurrent use of potent CYP3A4 inhibitors (7)History of organic heart disease or arrhythmia,or Baseline electrocardiograms indicating a QTc interval > 450 ms; (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)Participating in other clinical trials that affect the evaluation of the results of this study; (11)With other concominant diseases may affect the study according to the researcher's judgment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to stable analgesia;methadone conversion efficiency;pain relief ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity;daily frequency of BTP;methadone conversion ratios;Assessment of symptoms; | — |
Countries
China
Contacts
Public ContactGong Liyan
Zhejiang Cancer Hospital
Outcome results
None listed