This trial is active, not recruiting.

Condition neoplasm metastasis
Treatment dexamethasone
Phase phase 2
Sponsor University Health Network, Toronto
Collaborator Princess Margaret Hospital, Canada
Start date November 2003
End date November 2016
Trial size 50 participants
Trial identifier NCT00188864, UHN REB 03-0662-C


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases.
time frame:

Secondary Outcomes

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.
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Dexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study
Principal investigator Andrea Bezjak, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.