Dexamethasone for the Prophylaxis of Pain Flare Study

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: dexamethasone

• Registration Number: NCT00438828
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-22
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complete control of pain flare from Day 6-10 after the completion of radiation treatment.	Days 6-10
Functional interference especially mood and sleep in Brief Pain Inventory will be monitored.	Days 0, 1-10, and 6-weeks from baseline assessment
Quality of life outcomes	Baseline and 6-weeks following treatment

Trial Locations

Locations (1)

Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada