Dexamethasone for the Prophylaxis of Pain Flare Study

NCT00438828 | Completed Phase 1 DMC

• 2 other identifiers: SP-14-0055Sunnybrook REB# 057-2008
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

radiation therapy; palliative; pain

Outcome Measures

Primary Outcomes (1)

• Complete control of pain flare on days 1-5 after the completion of radiation treatment.

  Days 1-5

Secondary Outcomes (3)

• Complete control of pain flare from Day 6-10 after the completion of radiation treatment.

  Days 6-10

• Functional interference especially mood and sleep in Brief Pain Inventory will be monitored.

  Days 0, 1-10, and 6-weeks from baseline assessment

• Quality of life outcomes

  Baseline and 6-weeks following treatment

Study Arms (1)

Dexamethasone

EXPERIMENTAL

8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.

Drug: dexamethasone

Interventions

dexamethasone DRUG

8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.

Also known as: Decadron

Dexamethasone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Edward Chow, MBBS PhD

  edward.chow@sunnybrook.ca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: February 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

CA (1)