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Dexamethasone for the Prophylaxis of Pain Flare Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438828
First Posted: February 22, 2007
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Edward Chow, Sunnybrook Health Sciences Centre
  Purpose
Radiation treatment is often recommended as a safe and quick treatment that gives most people good relief from bone pain within a couple of weeks. However, some people can experience a short episode of increased pain (called a 'flare') a day or two after radiation treatment, that lasts about a day. The purpose of this sturdy is to find out if a medication called dexamethasone can help prevent pain flare as a result of radiation therapy.

Condition Intervention Phase
Cancer Drug: dexamethasone Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases

Resource links provided by NLM:


Further study details as provided by Dr. Edward Chow, Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Complete control of pain flare on days 1-5 after the completion of radiation treatment. [ Time Frame: Days 1-5 ]

Secondary Outcome Measures:
  • Complete control of pain flare from Day 6-10 after the completion of radiation treatment. [ Time Frame: Days 6-10 ]
  • Functional interference especially mood and sleep in Brief Pain Inventory will be monitored. [ Time Frame: Days 0, 1-10, and 6-weeks from baseline assessment ]
  • Quality of life outcomes [ Time Frame: Baseline and 6-weeks following treatment ]

Enrollment: 61
Study Start Date: February 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone
8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
Drug: dexamethasone
8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
Other Name: Decadron

Detailed Description:
Of all people diagnosed with cancer, 25% will have their cancer come back and spread to the bones. This often results in significant pain and suffering. Radiation treatment is often recommended as a safe and quick treatment that gives most people good relief from bone pain within a couple of weeks. However, some people can experience a short episode of increased pain called a flare a day or two after radiation treatment that lasts about a day. Studies suggest that around a third of all people who receive radiation treatment to help pain from cancer in the bones will have a pain flare. This study is being done because it would be helpful to prevent extra bone pain from happening to people after they receive radiation treatments. The purpose of this study is to find out if a medication called dexamethasone can help prevent pain flare as a result of radiation therapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented bone metastases by radiological imaging
  • Patients at least 18 years of age
  • Written consent
  • KPS ≥ 40
  • Baseline worst pain at the planned radiated bony metastatic site ≥ 2
  • Patient able to inform the pain score at the planned radiated bony metastatic site

Exclusion Criteria:

  • Concurrent use of any corticosteroid medication other than topical or inhaled preparations
  • Medical contraindications to corticosteroids such as diabetes mellitus, uncontrolled hypertension or active peptic ulcer
  • Pathological fracture of the irradiated extremity
  • Spinal cord compression
  • Language barrier
  • Immediate change in regular analgesic medication. If the oncologist thinks the patient is not receiving adequate analgesic, we recommend the oncologist to increase the analgesic first to stabilize ot lessen the pain before recruiting the patient to this study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438828


Locations
Canada, Ontario
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Study Chair: Edward Chow, MBBS PhD edward.chow@sunnybrook.ca
  More Information

Responsible Party: Dr. Edward Chow, Professor, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00438828     History of Changes
Other Study ID Numbers: SP-14-0055
Sunnybrook REB# 057-2008 ( Other Identifier: Sunnybrook Health Sciences Centre )
First Submitted: February 20, 2007
First Posted: February 22, 2007
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Dr. Edward Chow, Sunnybrook Health Sciences Centre:
radiation therapy
palliative
pain

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action