Dexamethasone for the Prophylaxis of Pain Flare Study

This study has been completed.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00438828
First received: February 20, 2007
Last updated: July 27, 2011
Last verified: July 2011
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete control of pain flare from Day 6-10 after the completion of radiation treatment. [ Time Frame: Days 6-10 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of life outcomes [ Time Frame: Baseline and 6-weeks following treatment ] [ Designated as safety issue: No ]

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 Names:
  • Dexamethasone
  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Edward Chow, MBBS PhD FRCPC, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00438828     History of Changes
Other Study ID Numbers: SP-14-0055, Sunnybrook REB# 057-2008
Study First Received: February 20, 2007
Last Updated: July 27, 2011
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
radiation therapy
palliative
pain

Additional relevant MeSH terms:
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 26, 2014