Dexamethasone for the Prophylaxis of Pain Flare Study

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Radiation treatment is often recommended as a safe and quick treatment that gives most people good relief from bone pain within a couple of weeks. However, some people can experience a short episode of increased pain (called a 'flare') a day or two after radiation treatment, that lasts about a day. The purpose of this sturdy is to find out if a medication called dexamethasone can help prevent pain flare as a result of radiation therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Documented bone metastases by radiological imaging

• Patients at least 18 years of age

• Written consent

• KPS ≥ 40

• Baseline worst pain at the planned radiated bony metastatic site ≥ 2

• Patient able to inform the pain score at the planned radiated bony metastatic site

Exclusion Criteria:

• Concurrent use of any corticosteroid medication other than topical or inhaled preparations

• Medical contraindications to corticosteroids such as diabetes mellitus, uncontrolled hypertension or active peptic ulcer

• Pathological fracture of the irradiated extremity

• Spinal cord compression

• Language barrier

• Immediate change in regular analgesic medication. If the oncologist thinks the patient is not receiving adequate analgesic, we recommend the oncologist to increase the analgesic first to stabilize ot lessen the pain before recruiting the patient to this study