Cancer pain Cancer pain
Conditions
Interventions
Study treatment group: over-capsulated methadone 5 mg or 10 mg for 2 weeks
Standard treatment group: over-capsulated oxycodone 10 mg or 20 mg for 2 weeks
Sponsors
Matsuoka Hiromichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unresectable advanced or recurrent malignant tumor. 2) Cancer pain (e.g., chest wall invasion, brachial plexus invasion, skull base invasion, sacral nerve plexus invasion, malignant psoas syndrome, bone metastasis pain, nerve root invasion, inflammatory breast cancer). 3) Age 18 or older at enrollment. 4) Karnofsky Performance Status (KPS) of 40 or higher at enrollment. 5) No methadone use within 28 days prior to enrollment. 6) Worst pain intensity in the past 24 hours (BPI item 3) of 4 or higher at enrollment. 7) On an appropriate dose of opioid analgesics (oral morphine equivalent dose (OMED) of equal to or greater than 60 mg and equal to or less than 300 mg) at enrollment. 8) Total bilirubin is no more than 1.5 mg/dL, and AST and ALT are no more than 100 U/L, and creatinine clearance is at least 40 mL/min and/or the estimated glomerular filtration rate based on serum cystatin C is at least 40 mL/min/1.73 m2. 9) Serum potassium level of 3.5 mmol/L or higher. 10) QTcB is less than 450 msec by simplified ECG measurement, or QTcB is less than 450 msec by measurement performed by a cardiologist 11) Provided written informed consent for participation at enrollment.
Exclusion criteria
Exclusion criteria: 1) Patients with myocardial infarction(i), New York Heart Association class III or IV heart failure, angina pectoris under active treatment, or QT prolongation with a corrected QT interval of more than 450 milliseconds(ii). (i) Patients with a remote history of myocardial infarction are eligible for enrollment. (ii) Among patients with acquired long QT syndrome, those in whom the causative factor has been removed and the corrected QT interval has improved to no more than 450 milliseconds are eligible for enrollment. 2) Currently taking antiarrhythmic drugs. 3) Experiencing nausea and somnolence of CTCAE v5.0-JCOG Grade 2 or higher at registration. 4) Presenting with constipation of CTCAE v5.0-JCOG Grade 3 or higher at registration. 5) Currently participating in or planning to participate in a clinical trial or investigational study. 6) Has newly added scheduled doses of analgesics or other adjuvant analgesics within 48 hours before enrollment. 7) Has newly added any of the following drugs (new chemotherapy, molecular targeted agents, or immune checkpoint inhibitors) or treatments (nerve blocks) within seven days prior to registration, or who plan to add any of these within seven days after registration. 8) Contraindications for methadone (patients with severe respiratory depression, severe chronic obstructive pulmonary disease, bronchial asthma attacks, paralytic ileus, acute alcohol intoxication, hypersensitivity to methadone, hemorrhagic colitis, patients receiving nalmefene or within one week after discontinuation). 9) Has allergies or a history of hypersensitivity to opioid compounds. 10) Has used, or plan to use, within seven days prior to registration, medications that strongly affect CYP3A4, including supplements and foods or supplements containing St. John's wort that have inducing effects on the drug-metabolizing enzyme CYP3A4. 11) Pregnant, breastfeeding, needs to continue breastfeeding after the start of the investigational drug, or possibly pregnant. 12) Has psychiatric disorders or psychiatric symptoms that interfere with daily life and are deemed to make participation in the study difficult. 13) Deemed inappropriate for the study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-week study treatment completion rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number of participants registered during 12 months. 2) Change in the worst pain Numeric Rating Scale (NRS) (Brief Pain Inventory (BPI) item 3) in the past 24 hours from baseline to 2 weeks. 3) Change in the worst pain intensity (BPI item 3) from baseline to 1 week. 4) Change in the average pain intensity (BPI item 5) from baseline to 1 week and 2 weeks. 5) Proportion of participants achieving a reduction of 1, 2, 3, or 4 or more in BPI items 3 and 5 from baseline to 1 week and 2 weeks. 6) Proportion of participants achieving a reduction of 30 percent or more and 50 percent or more in BPI items 3 and 5 from baseline to 1 week and 2 weeks. 7) Number of days to achieve good pain control, defined as BPI item 3 score of 3 or less and BPI item 5 score of 3 or less. 8) Number of days to achieve a reduction of 2 or more, 3 or more, 30 percent or more, and 50 percent or more in BPI items 3 and 5 from baseline. 9) Proportion of participants needing a reduction in adjuvant analgesics and an increase or decrease in opioids or methadone by 2 weeks compared to baseline. 10) Effective proportion of each intervention group in patients with neuropathic pain, as defined by the International Association for the Study of Pain (IASP) criteria, at 1 week and 2 weeks, measured by a reduction of 2 or more and 3 or more in BPI items 3 and 5 from baseline. 11) Effective proportion of each intervention group in patients with neuropathic pain, as defined by the International Association for the Study of Pain (IASP) criteria, at 1 week and 2 weeks, measured by a reduction of 30 percent or more and 50 percent or more in BPI items 3 and 5 from baseline. 12) Scores on the Short Form McGill Pain Questionnaire 2 (SF-MPQ-2). 13) Proportion of participants achieving their Personalized Pain Goal (PPG), defined as the Numeric Rating Scale (NRS) score indicating the level of pain at which they can feel at ease. Achievement of the PPG is defined as the 24-hour average pain NRS (BPI item 5) being equal | — |
Contacts
Public ContactTakako Ikegami
National Cancer Center Hospital
Outcome results
None listed