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Sponsors and Collaborators: |
University Health Network, Toronto Princess Margaret Hospital, Canada |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00188864 |
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.
Condition | Intervention | Phase |
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Neoplasm Metastasis |
Drug: dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Dexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study |
Estimated Enrollment: | 50 |
Study Start Date: | November 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Bezjak, MD | 416-946-2132 | andrea.bezjak@rmp.uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Andrea Bezjak, MD 416-946-2132 andrea.bezjak@rmp.uhn.on.ca |
Principal Investigator: | Andrea Bezjak, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | UHN REB 03-0662-C |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00188864 |
Health Authority: | Canada: Ethics Review Committee |
Dexamethasone Neoplasm Metastasis Dexamethasone acetate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Glucocorticoids Hormones |
Pharmacologic Actions Neoplastic Processes Neoplasms Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |