Dexamethasone for the Prophylaxis of Pain Flare Study
November 17, 2014 updated by: Dr. Edward Chow, Sunnybrook Health Sciences Centre
Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dexamethasone
8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
|
8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complete control of pain flare on days 1-5 after the completion of radiation treatment.
Time Frame: Days 1-5
|
Days 1-5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complete control of pain flare from Day 6-10 after the completion of radiation treatment.
Time Frame: Days 6-10
|
Days 6-10
|
|
Functional interference especially mood and sleep in Brief Pain Inventory will be monitored.
Time Frame: Days 0, 1-10, and 6-weeks from baseline assessment
|
Days 0, 1-10, and 6-weeks from baseline assessment
|
|
Quality of life outcomes
Time Frame: Baseline and 6-weeks following treatment
|
Baseline and 6-weeks following treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Edward Chow, MBBS PhD, edward.chow@sunnybrook.ca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 20, 2007
First Submitted That Met QC Criteria
February 20, 2007
First Posted (Estimate)
February 22, 2007
Study Record Updates
Last Update Posted (Estimate)
November 19, 2014
Last Update Submitted That Met QC Criteria
November 17, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP-14-0055
- Sunnybrook REB# 057-2008 (Other Identifier: Sunnybrook Health Sciences Centre)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.