Status:
NOT_YET_RECRUITING
Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy
Lead Sponsor:
American University of Beirut Medical Center
Conditions:
Bone Pain Flare
Bone Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Solid tumors have the tendency to spread to other organs in around 26% of cases, with many cases involving the bone causing severe bone destruction and pain that reduces patients' quality of life. Pal...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Primary Solid tumor (Any type of solid tumor)
- Painful bone metastases which are otherwise uncomplicated (no fracture and no neurologic symptoms due to nerve impingement or compression)
- Baseline pain score on a numeric rating scale (0-10) of at least 2
- Stable dose and schedule of narcotic medications prescribed
Exclusion
- Hematologic malignancy
- Previously irradiated bone
- Current use of steroids
- Current use of NSAIDs which cannot be stopped before randomization
- Contraindications for NSAIDs (hypersensitivity, PUD, prior GI bleed, CKD, HTN, HF, AERD/asthma)
- Contraindications for PPIs
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT06903585
Start Date
April 1 2025
End Date
April 1 2029
Last Update
April 4 2025
Active Locations (1)
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1
American University of Beirut Medical Center
Beirut, Lebanon, 1107 - 2020