Completed

Dexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study

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What is being tested

Data Collection

Who is being recruted

Neoplasm Metastasis+2

+ Neoplasms

+ Neoplastic Processes

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorUniversity Health Network, Toronto
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleDexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study
NCT00188864
Principal SponsorUniversity Health Network, Toronto
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasm MetastasisNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

5 inclusion criteria required to participate
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

Show More Criteria

4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Princess Margaret Hospital

Toronto, CanadaOpen Princess Margaret Hospital in Google Maps
CompletedOne Study Center