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Dexamethasone for Palliation - Brain Metastases
This study is currently recruiting participants.
Verified by University Health Network, Toronto, September 2005
Sponsors and Collaborators: University Health Network, Toronto
Princess Margaret Hospital, Canada
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188864
  Purpose

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
Neoplasm Metastasis
Drug: dexamethasone
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus
U.S. FDA Resources
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

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To perform an adequate statistical evaluation of patients regarding the role of steroid therapy in managing patients with cerebral metastases.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 50
Study Start Date: November 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188864

Contacts
Contact: Andrea Bezjak, MD 416-946-2132 andrea.bezjak@rmp.uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrea Bezjak, MD     416-946-2132     andrea.bezjak@rmp.uhn.on.ca    
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Andrea Bezjak, MD Princess Margaret Hospital, Canada
  More Information

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

Study placed in the following topic categories:
Dexamethasone
Neoplasm Metastasis
Dexamethasone acetate

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009