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OpenTrials
Completed

NCT Number: NCT00438828

Dexamethasone for the Prophylaxis of Pain Flare Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Other names: Decadron

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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Feb 22, 2007
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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