Dexamethasone for Palliation - Brain Metastases
Primary Purpose
Neoplasm Metastasis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis
Eligibility Criteria
Inclusion Criteria: Known diagnosis of cancer (even if primary unknown) Brain metastases (single or multiple) confirmed by imaging (CT, MRI) No contraindication for RT/steroids Patient will be treated with Whole Brain Radiation Therapy Informed consent Exclusion Criteria: Primary cancer is lymphoma or leukemia Complete surgical excision of brain metastases Patient was on steroids for more then 2 weeks prior to entering the study Confusion or other factors that would impair ability to assess symptoms
Sites / Locations
- Princess Margaret Hospital
Outcomes
Primary Outcome Measures
To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases.
Secondary Outcome Measures
To observe whether DXM 8mg qAM for symptomatic patients and DXM 4mg qAM for asymptomatic patients is effective in maintaining symptom control without neurological deterioration that necessitates the patient to go back to a higher dose.
Full Information
NCT ID
NCT00188864
First Posted
September 12, 2005
Last Updated
November 25, 2019
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00188864
Brief Title
Dexamethasone for Palliation - Brain Metastases
Official Title
Dexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
January 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. Study Description
Brief Summary
Brain metastases occur when cancer cells from the initial tumour site (for example, lung or breast) spread to the brain. This develops in approximately 10% - 30% of adults with cancer. They can produce different complaints related to their effect on brain functioning, decrease in a person's ability to carry on with their usual activities, a reduction in the quality of life and shortened life expectancy.
The standard treatment particularly for people with more than one brain metastasis consists of palliative radiation therapy to the brain and steroids. Steroids (such as Decadron or Dexamethasone) are medication used to reduce swelling around the tumour, and thus symptoms improve. Steroids could be very helpful but have a number of potential side effects, particularly if used for longer periods of time. There is no standard dose of Decadron used in treating brain metastases patients. The most commonly dose used is 4 mg four times/day.
This study will assess if lower doses of Decadron - 8 mg every morning for symptomatic patients and 4 mg every morning for asymptomatic patients - are effective in maintaining symptom control in patients with brain metastases, without neurological deterioration that necessitates the patient to go back or to a higher dose at any time. This information will help also in understanding how to decrease the side effects associated with higher doses of steroids in people with your condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Primary Outcome Measure Information:
Title
To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases.
Secondary Outcome Measure Information:
Title
To observe whether DXM 8mg qAM for symptomatic patients and DXM 4mg qAM for asymptomatic patients is effective in maintaining symptom control without neurological deterioration that necessitates the patient to go back to a higher dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Known diagnosis of cancer (even if primary unknown)
Brain metastases (single or multiple) confirmed by imaging (CT, MRI)
No contraindication for RT/steroids
Patient will be treated with Whole Brain Radiation Therapy
Informed consent
Exclusion Criteria:
Primary cancer is lymphoma or leukemia
Complete surgical excision of brain metastases
Patient was on steroids for more then 2 weeks prior to entering the study
Confusion or other factors that would impair ability to assess symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Bezjak, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
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Dexamethasone for Palliation - Brain Metastases
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