Dexamethasone for the Prophylaxis of Pain Flare Study

Sunnybrook Health Sciences Centre

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00438828

Sunnybrook REB# 057-2008 (Other Identifier)

SP-14-0055

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Dexamethasone

Experimental group

Description:

8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.

Treatment:

Drug: dexamethasone