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CompletedNCT00438828Updated Nov 19, 2014

Dexamethasone for the Prophylaxis of Pain Flare Study

A Phase 1 interventional study of dexamethasone in Cancer, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-19.

Sponsored by Sunnybrook Health Sciences Centre · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer

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Keywords

  • radiation therapy
  • palliative
  • pain
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 61 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 582 studies on the registry; 133 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Dexamethasone

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

    Drug: dexamethasone

Interventions

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

    Also known as: Decadron

06

What researchers measure

Primary outcomes

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

    Time frame: Days 1-5

Secondary outcomes

  1. Complete control of pain flare from Day 6-10 after the completion of radiation treatment.

    Time frame: Days 6-10

  2. 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

  3. Quality of life outcomes

    Time frame: Baseline and 6-weeks following treatment

07

Study locations

1 site
  • Odette Cancer Centre
    Toronto, Ontario M4N 3M5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00438828
Responsible party
Dr. Edward Chow (Professor, Sunnybrook Health Sciences Centre) — Principal investigator
First posted
Feb 22, 2007
Start date
Feb 2007
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Nov 19, 2014

Study contacts

Edward Chow, MBBS PhD
study chair · edward.chow@sunnybrook.ca

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexamethasone

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