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Dexamethasone for the Prophylaxis of Pain Flare Study

NCT ID: NCT00438828

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexamethasone

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

Group Type EXPERIMENTAL

dexamethasone

Intervention Type DRUG

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

Interventions

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dexamethasone

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

Intervention Type DRUG

Other Intervention Names

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Decadron

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Edward Chow

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward Chow, MBBS PhD

Role: STUDY_CHAIR

[email protected]

Locations

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Odette Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Sunnybrook REB# 057-2008

Identifier Type: OTHER

Identifier Source: secondary_id

SP-14-0055

Identifier Type: -

Identifier Source: org_study_id