Dexamethasone for Palliation - Brain Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188864
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 12, 2005
September 12, 2005
November 2003
Not Provided
To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases.
Same as current
No Changes Posted
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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasm Metastasis
Drug: dexamethasone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Andrea Bezjak, MD 416-946-2132 andrea.bezjak@rmp.uhn.on.ca
Canada
 
NCT00188864
UHN REB 03-0662-C
Not Provided
Not Provided
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Andrea Bezjak, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
September 2005

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