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

Status

Completed

Conditions

Intervention / Treatment

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

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

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.

Sponsor

Sunnybrook Health Sciences Centre

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.

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