This is an open-label, single arm, Phase Ib dose escalation study of Oxcarbazepine with morphine in patients with refractory cancer pain. The primary endpoint is to evaluate the safety and toxicity of the combination of Oxcarbazepine plus morphine. The secondary endpoints are improving pain control, reduce morphine use and improve the quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1
Morphine will be given to patients as part of their standard care
Can be taken with or without food at the same time as morphine. Morphine will be provided to patients free of charge.
Indiana Univeristy Health Hospital
Indianapolis, Indiana, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Number of patients with adverse events as a measure of safety and toxicity
Evaluate the safety and toxicity of oxcarbazepine in combination with morphine
Time frame: 1 year
Changes in Pain control
Evaluate changes in pain control after adding oxcarbazepine to morphine
Time frame: 1 year
Changes in Consumption
Evaluate changes morphine consumption after adding oxcarbazepine to morphine
Time frame: 1 year
Changes in Quality of Life
Evaluate changes in Quality of Life after adding oxcarbazepine to morphine
Time frame: 1 year
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