Dexamethasone for Palliation - Brain Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188864
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dexamethasone as Palliative Treatment in Addition to Radiation Therapy for Patients With Brain Metastases: A Prospective Study

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00188864     History of Changes
Other Study ID Numbers: UHN REB 03-0662-C
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014