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Dexamethasone for Palliation - Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188864
Recruitment Status : Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : December 29, 2016
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

September 12, 2005
September 16, 2005
December 29, 2016
November 2003
November 2017   (Final data collection date for primary outcome measure)
To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases.
Same as current
Complete list of historical versions of study NCT00188864 on Archive Site
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.
Same as current
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Dexamethasone for Palliation - Brain Metastases
Dexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study

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.

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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasm Metastasis
Drug: dexamethasone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
November 2017
November 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
UHN REB 03-0662-C
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University Health Network, Toronto
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Andrea Bezjak, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP