Cancer Pain
Conditions
Interventions
Duloxetine Group Treatment Period: 10 days (titration on day 3) Dose: Duloxetine 20-40mg/day every morning
Placebo Group Treatment Period: 10 days (titration on day 3) Dose: Placebo 1cap-2cap/day
Sponsors
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cancer patients with neuropathic pain 2) Regularly scheduled systemic opioid therapy with insufficient analgesia 3) Non-responsive or intolerant to gabapentinoids 4) HADS<20 5) Age >= 20 6) Pain NRS(BPI item-4) >= 4 7) Creatinine clearance < 60 ml/min 8) AST<100 IU/L,ALT<100 IU/L,T-bil<2.0 mg/dl 9) Expected at least one month survival 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Chemotherapy-induced Peripheral Neuropathy 2) Progressive paralysis 3) Allergy to duloxetine 4) Depression 5) Patients who changed analgesic adjuvant agents within 2 days 6) Drug dependence or abuse 7) Uncontrolled psychiatric disease 8) Pregnancy or lactating patients 9) Patients who are judged as inadequate to participate to the trial due to other reasons by the doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain NRS (BPI-item4, 24-hour average intensity of global pain)on Day10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital anxiety and depression scale, Short-Form Mcgill Pain Questionnaire 2, European Organization for Research and Treatment of Cancer Quority of Life Questionnaire Core 15 palliative, Pain Catastrophizing Scale, Adverse Events, Rescue dose, Pain NRS on Day10 by subgroups (nonresponsive or intolerant to gabapentinoids) | — |
Countries
Japan
Contacts
Public ContactHiromichi Matsuoka
Kinki University, Faculty of Medicine Department of Psychosomatic Medicine
Outcome results
None listed