Dexamethasone for the Prophylaxis of Pain Flare Study | NCT00438828

Studies
Dexamethasone for the Prophylaxis of Pain Flare Study

NCT00438828

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Nov 19, 2014Estimated

Enrollment

61Actual

Phase

Phase 1

Conditions

Cancer

Interventions

dexamethasone

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Sunnybrook REB# 057-2008	Other Identifier	Sunnybrook Health Sciences Centre

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Feb 20, 2007

First Submission Date that Met QC Criteria

Feb 20, 2007

First Posted Date

Feb 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone	Experimental	8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.	Drug: dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dexamethasone	Drug	8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.	Dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete control of pain flare on days 1-5 after the completion of radiation treatment.		Days 1-5

Secondary Outcomes

Measure	Description	Time Frame
Complete control of pain flare from Day 6-10 after the completion of radiation treatment.		Days 6-10
Functional interference especially mood and sleep in Brief Pain Inventory will be monitored.		Days 0, 1-10, and 6-weeks from baseline assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward Chow, MBBS PhD	edward.chow@sunnybrook.ca	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odette Cancer Centre		Toronto	Ontario	M4N 3M5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D002123	Calcium Dobesilate

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided