Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Days 1-5

Safety Issue:


Principal Investigator

Edward Chow, MBBS PhD

Investigator Role:

Study Chair

Investigator Affiliation:


Canada: Health Canada

Study ID:




Start Date:

February 2007

Completion Date:

July 2011

Related Keywords:

  • Cancer
  • radiation therapy
  • palliative
  • pain