Opioid Titration With 12.5 ug/h Fentanyl Transdermal Patch vs Orally Morphine for Opioid-naïve Patients With Moderate Cancer Pain

This is an interventional treatment trial for Opioid, Moderate Cancer Pain, Transdermal Fentanyl, 12.5ug/h, Opioid-naive Read More

Inclusion Criteria:

1. Age 18 years old or more;
2. ECOG PS ≤3 ;
3. Opioid tolerance not moderate pain patients (4≤ NRS ≤6 on 11 points, 0 no pain, 10 most pain);
4. No taking strong opioids for the last 30 days;
5. Estimated life expectancy of at least 3 months;
6. Ability to communicate effectively with the study personnel about the nature of their pain;
7. Ability to complete a diary;
8. Cancer pain is expected to be relatively stable and last for more than 48 hours;
9. The patient understands the research process, agrees to participate in the trial, cooperates with the treatment and visit plan, and signs an informed consent form.

Exclusion Criteria:

1. Known allergy to any ingredient in both fentanyl and morphine;
2. No cancer associated pain or the pain of unknown cause, such as osteoarthritis pain, acute abdominal pain;
3. Primary tumors or metastases in the brain;
4. An active skin disease that precluded application of the transdermal system;
5. Anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, etc.) is used during the study period, and the treatment has an impact on the analgesic effect or adverse reactions of analgesic drugs;
6. No bowel movement within 3 days before the screening period;
7. The patient has contraindications to the use of opioids: such as respiratory depression; head damage; paralytic intestinal obstruction; acute abdomen; chronic obstructive airway disease; pulmonary heart disease; chronic bronchial asthma; hypercapnia;
8. Used monoamine oxidase inhibitor within 1 week before randomization;
9. Any abnormal laboratory test results with obvious clinical significance, such as creatinine value ≥ 2 times the high limit of the normal value or ALT or AST ≥ 2.5 times the high limit of the normal value (for patients with liver metastases can be relaxed to ≥ 5 times the high limit of the normal value) ;
10. Patients with a history of drug abuse;
11. Patients with mental illness or cognitive impairment;
12. Pregnant or lactating women; subjects who have a pregnancy plan within 1 month after the test (including male subjects);
13. Participate in the drug trial (including the trial drug) within 3 months before the trial.