Dexamethasone for Palliation - Brain Metastases
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dexamethasone for Palliation - Brain Metastases | ||||
| Official Title ICMJE | Dexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study | ||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neoplasm Metastasis | ||||
| Intervention ICMJE | Drug: dexamethasone | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00188864 | ||||
| Other Study ID Numbers ICMJE | UHN REB 03-0662-C | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE | Princess Margaret Hospital, Canada | ||||
| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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