Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
18 Years
N/A
Both
Cancer
Trial Information
Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
Of all people diagnosed with cancer, 25% will have their cancer come back and spread to the
bones. This often results in significant pain and suffering. 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. Studies
suggest that around a third of all people who receive radiation treatment to help pain from
cancer in the bones will have a pain flare. This study is being done because it would be
helpful to prevent extra bone pain from happening to people after they receive radiation
treatments. The purpose of this study is to find out if a medication called dexamethasone
can help prevent pain flare as a result of radiation therapy.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete control of pain flare on days 1-5 after the completion of radiation treatment.
Outcome Time Frame:
Days 1-5
Safety Issue:
No
Principal Investigator
Edward Chow, MBBS PhD
Investigator Role:
Study Chair
Investigator Affiliation:
edward.chow@sunnybrook.ca
Authority:
Canada: Health Canada
Study ID:
SP-14-0055
NCT ID:
NCT00438828
Start Date:
February 2007
Completion Date:
July 2011
Related Keywords:
- Cancer
- radiation therapy
- palliative
- pain
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