The purpose of this study is to find out if Radium-223 is effective in reducing cancer pain within 12 weeks of treatment. In order to see if Radium-223 is effective, the patient's level of pain will be followed throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
29
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Percentage of Participants With 30% Decline in the Brief Pain Inventory (BPI) Worst Pain Item From Baseline to Week 8
Defined as a 30% decline in the Brief Pain Inventory/BPI worse pain item from baseline to week 8, with a confirmed reduction at week 12 without an escalation of the subject's pain regimen from Step 1 to Step 2 or Step 2 to Step 3 of the WHO analgesic ladder.) The baseline BPI worst pain score average will be based on the worst pain scores completed by the participant in the 7 consecutive pretreatment days. A minimum of 4 days of pain scores must be completed by the participant in the 7 day window in order to calculate the average worst pain score. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Time frame: 8 weeks
Number of Participants With Changes in Bone Alkaline Phosphatase (ALP)
Number of participants with changes from baseline to 12 weeks (or earlier for those who discontinue study therapy). Maximum change (rise or fall) in bone Alkaline phosphatase (ALP) during the treatment period reported.
Time frame: 12 weeks
Number of Participants With Changes in Other Bone Markers:
Serum C-telopeptide (sCTX-1) N-terminal propeptide of procollagen type 1 (PINP) Changes in total-ALP will be defined as for bone-ALP above
Time frame: 1 year
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