CompletedPhase 1

Dexamethasone for the Prophylaxis of Pain Flare Study

Canada61 participantsStarted 2007-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Complete control of pain flare on days 1-5 after the completion of radiation treatment.

Timeframe: Days 1-5

Trial details

NCT IDNCT00438828

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-07

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