Dexamethasone for Palliation - Brain Metastases

NCT00188864 | Completed Phase 2

• 1 other identifier: UHN REB 03-0662-C
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

dexamethasone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Andrea Bezjak, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: January 28, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

CA (1)