CancerPhase 1NCT00438828
Dexamethasone for the Prophylaxis of Pain Flare Study
A Phase 1 study testing dexamethasone in people with Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- dexamethasone
- Keywords
- radiation therapy, palliative, pain
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Also called Decadron
8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | 8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment. Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete control of pain flare on days 1-5 after the completion of radiation treatment.
Measured: Days 1-5
Secondary outcomes (3)
Complete control of pain flare from Day 6-10 after the completion of radiation treatment.
Measured: Days 6-10
Functional interference especially mood and sleep in Brief Pain Inventory will be monitored.
Measured: Days 0, 1-10, and 6-weeks from baseline assessment
Quality of life outcomes
Measured: Baseline and 6-weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Edward Chow, Sunnybrook Health Sciences Centre
- Investigators
- Edward Chow, MBBS PhD, Study chair, edward.chow@sunnybrook.ca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438828
- Sponsor's protocol ID
- SP-14-0055
- Other IDs
- Sunnybrook REB# 057-2008
- Status last verified
- Nov 2014
- First submitted
- 20 Feb 2007
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
- ClinicalTrials.gov ID
- NCT00438828
- Acronym / sponsor ID
- SP-14-0055
- Conditions
- Cancer
- Keywords
- radiation therapy, palliative, pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: dexamethasone8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasoneAlso: Decadron8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment. | Drug | Dexamethasone |
Primary outcome
Complete control of pain flare on days 1-5 after the completion of radiation treatment.
Time frame: Days 1-5
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Chow, MBBS PhD study chair
edward.chow@sunnybrook.ca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dexamethasone in people with Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete control of pain flare on days 1-5 after the completion of radiation treatment. (time frame: Days 1-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.