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Dexamethasone for the Prophylaxis of Pain Flare Study

Information source: Sunnybrook Health Sciences Centre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer

Intervention: dexamethasone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sunnybrook Health Sciences Centre

Official(s) and/or principal investigator(s):
Edward Chow, MBBS PhD, Study Chair, Affiliation: edward.chow@sunnybrook.ca

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

Functional interference especially mood and sleep in Brief Pain Inventory will be monitored.

Quality of life outcomes

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Odette Cancer Centre, Toronto, Ontario M4N 3M5, Canada
Additional Information

Starting date: February 2007
Last updated: November 17, 2014

Page last updated: August 23, 2015

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