Dexamethasone for the Prophylaxis of Pain Flare Study

Cancer Clinical Trial

Official title:

Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438828
• Other study ID #: SP-14-0055
• Secondary ID: Sunnybrook REB#
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2007
• Last updated: November 17, 2014
• Start date: February 2007
• Est. completion date: July 2011

Study information

• Verified date: November 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete control of pain flare on days 1-5 after the completion of radiation treatment.		Days 1-5	No
Secondary	Complete control of pain flare from Day 6-10 after the completion of radiation treatment.		Days 6-10	No
Secondary	Functional interference especially mood and sleep in Brief Pain Inventory will be monitored.		Days 0, 1-10, and 6-weeks from baseline assessment	No
Secondary	Quality of life outcomes		Baseline and 6-weeks following treatment	No