To evaluate the safety and tolerance of Hawthorn red pigment in the treatment of cancer pain Determine the maximum tolerated dose (MTD, if any) of Hawthorn red pigment and the recommended dose for phase II clinical study (RP2D)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
For patients with refractory cancer pain who meet the enrollment conditions, on the basis of the clinician's normal adjustment of the analgesic regimen (the initial adjustment is the first day), the dose ramp up study of Hawthorn red pigment was started on the third day. The Hawthorn red dose group includes 10 tablets → 15 tablets → 20 tablets / time, orally, twice a day. "3 + 3" dose escalation scheme
AE, SAE and DLT, MTD (if any), RP2D
Occurrence and frequency of AE, SAE and DLT, MTD (if any), RP2D, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 month
Average pain score
Change in average pain score (NRS 0-10, 0 = painless, 10 = most painful)
Time frame: 1 month
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