VomitingPhase 3NCT01135550
Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation
A Phase 3 study testing High dose dexamethasone and Low dose dexamethasone in people with Vomiting and Headache, run by The Hospital for Sick Children at 5 sites in Canada.
Trial summary
The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- What is being tested?
- High dose dexamethasone and Low dose dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesCanada
- Study dates
- Jun 2010to Dec 2013
- Phase
- Phase 3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between 2-18 years of age.
- Children who underwent resection of a brain tumour with ≤ 1.5 cm2 residual tumour after surgical resection.
- Children regardless of extent of leptomeningeal or spinal metastasis (M1-3) are eligible.
- Children who undergo focal or whole brain (± spinal) radiation as part of their brain tumour treatment.
- Children treated at one of the 16 tertiary care centers in Canada (CPBTC).
- Patients on any anticonvulsive treatment are eligible.
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- Patients on concomitant chemotherapy while undergoing radiation are eligible.
- Patients must be ≥ 24 hours steroid-free prior to starting radiation.
- Parents/legal guardians have to have signed and dated an informed consent to allow study enrolment of their child. (As per institutional guidelines, patients over a certain age may have signed their own informed consent form.)
- Patients > 8 years of age should assent to study participation.
- Patients less than 10 years of age should have a Lansky Score of >/= 50.
- Patients 10 years of age or older should have a Karnofsky Score of >/= 50. If ECOG performance scale is used, patient should have a score of 0, 1 or 2.
Who cannot join
- Children with residual brain tumour lesion > 1.5 cm2 after surgical resection.
- Children on steroids (dexamethasone) that will not be stopped ≥ 24 hours prior to start of radiation therapy.
- Inclusion Criteria for Randomization to a Dexamethasone treatment group:
- Patients must have been enrolled on the Dexamethasone study prior to the start of radiation therapy.
- Children who develop either symptoms of vomiting (defined as either retching or vomiting ≥ once per day) or headache (≥ 2 points increase in severity of the most intense headache/day) while undergoing irradiation.
- Patients who are currently undergoing focal or whole brain (± spinal) radiation.
- Exclusion Criteria for Randomization to a Dexamethasone treatment group:
- Patients who were not enrolled on Dexamethasone study prior to start of radiation therapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Alberta Children's Hospital
Calgary, Alberta
McMaster University Hospital
Hamilton, Ontario
Children's Hospital of Western Ontario
London, Ontario
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia
About this study
Official title: A RANDOMIZED CONTROLLED MULTICENTER NON-INFERIORITY TRIAL OF TWICE DAILY LOW DOSE DEXAMETHASONE VERSUS USUAL DOSE DEXAMETHASONE FOR SYMPTOM CONTROL IN CHILDREN WITH A BRAIN TUMOUR UNDERGOING CRANIAL OR CRANIOSPINAL RADIATION
The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.
Read the detailed description
Dexamethasone is an effective medication to ameliorate radiation induced headache and vomiting. In our Toronto experience dexamethasone in low doses (1 mg/m2/day) is sufficient in treating these symptoms. However this experience is not shared from many neuro-oncology centers of excellence that more commonly use 5 mg/m2/day according to the results of the trans-Canadian survey. A prospective multicenter trial evaluating the effectiveness of dexamethasone in different dose regimens in symptomatic children while undergoing CNS radiation will elucidate the appropriate dose.
- Being tested
- High dose dexamethasone, Low dose dexamethasone
- Keywords
- Pediatrics, Vomiting, Headache, Radiation Therapy
- Medical subject headings
- Vomiting, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose dexamethasoneDrug
Subject will receive 5 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form.
If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4.
Low dose dexamethasoneDrug
Subject will receive 1 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form.
If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | Active comparator | Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience.
If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms. Receives: Drug: High dose dexamethasone |
| Control Arm | Active comparator | Subjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience.
If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms. Receives: Drug: Low dose dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of dexamethasone on vomiting
The primary outcome will be the evaluation of effectiveness of dexamethasone on vomiting after 24-48 hours (after 2-4 doses of treatment). Vomiting is defined as either retching or vomiting and will be counted in events. The frequency of emetic episodes/day will be documented in the daily diary. The effectiveness of dexamethasone will be counted in number of episodes and evaluated on day 2 (48 hours after first dose).
Measured: 24-48 hours after first dose of dexamethasone
Secondary outcomes (3)
Headaches
Parent/patients are asked to document the worst headache of the day prior to bedtime daily on a visual analogue scale using the 6-face "happy face" scale ranging from 0 (no headache) to 5 (extreme headache).
Measured: 0-48 hours after first dose of dexamethasone
Adverse events and side effects
These will be described with numbers, type and frequencies for the duration of the subjects participation in the study.
Measured: Duration of participation in study
Quality of life
Parent/patient will complete a quality of life assessment within 14 days prior to starting radiation (including first day of radiation) and within 14 days post completion of radiation (including last day of radiation).
Measured: Baseline and at end of participation in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: premature closure due to lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- C17 Council
- Responsible party
- Principal investigator, Ute Bartels, The Hospital for Sick Children
- Investigators
- Ute Bartels, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135550
- Sponsor's protocol ID
- 1000014713
- Status last verified
- May 2016
- First submitted
- 1 Jun 2010
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED CONTROLLED MULTICENTER NON-INFERIORITY TRIAL OF TWICE DAILY LOW DOSE DEXAMETHASONE VERSUS USUAL DOSE DEXAMETHASONE FOR SYMPTOM CONTROL IN CHILDREN WITH A BRAIN TUMOUR UNDERGOING CRANIAL OR CRANIOSPINAL RADIATION
- ClinicalTrials.gov ID
- NCT01135550
- Acronym / sponsor ID
- 1000014713
- Keywords
- Pediatrics, Vomiting, Headache, Radiation Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: premature closure due to lack of accrual
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- C17 Council
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Jun 2010 (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.
The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.
Detailed description
Dexamethasone is an effective medication to ameliorate radiation induced headache and vomiting. In our Toronto experience dexamethasone in low doses (1 mg/m2/day) is sufficient in treating these symptoms. However this experience is not shared from many neuro-oncology centers of excellence that more commonly use 5 mg/m2/day according to the results of the trans-Canadian survey. A prospective multicenter trial evaluating the effectiveness of dexamethasone in different dose regimens in symptomatic children while undergoing CNS radiation will elucidate the appropriate dose.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | Active comparator | Drug: High dose dexamethasoneSubjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience. If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms. |
| Control Arm | Active comparator | Drug: Low dose dexamethasoneSubjects scheduled to undergo radiation therapy are enrolled before the therapy is started. Once radiation therapy begins they will complete a daily diary about any headaches or nausea/vomiting they experience. If they experience increased headache or vomiting they will be randomized to receive either a high or a low dose of dexamethasone, to control these symptoms. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Children between 2-18 years of age.
- Children who underwent resection of a brain tumour with ≤ 1.5 cm2 residual tumour after surgical resection.
- Children regardless of extent of leptomeningeal or spinal metastasis (M1-3) are eligible.
- Children who undergo focal or whole brain (± spinal) radiation as part of their brain tumour treatment.
- Children treated at one of the 16 tertiary care centers in Canada (CPBTC).
Key exclusion criteria (8 listed)
- Children with residual brain tumour lesion > 1.5 cm2 after surgical resection.
- Children on steroids (dexamethasone) that will not be stopped ≥ 24 hours prior to start of radiation therapy.
- Patients must have been enrolled on the Dexamethasone study prior to the start of radiation therapy.
- Children who develop either symptoms of vomiting (defined as either retching or vomiting ≥ once per day) or headache (≥ 2 points increase in severity of the most intense headache/day) while undergoing irradiation.
- Patients who are currently undergoing focal or whole brain (± spinal) radiation.
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 |
|---|---|---|
| High dose dexamethasoneSubject will receive 5 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form. If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4. | Drug | Standard Arm |
| Low dose dexamethasoneSubject will receive 1 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form. If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4. | Drug | Control Arm |
Primary outcome
Effectiveness of dexamethasone on vomiting
Time frame: 24-48 hours after first dose of dexamethasone
The primary outcome will be the evaluation of effectiveness of dexamethasone on vomiting after 24-48 hours (after 2-4 doses of treatment). Vomiting is defined as either retching or vomiting and will be counted in events. The frequency of emetic episodes/day will be documented in the daily diary. The effectiveness of dexamethasone will be counted in number of episodes and evaluated on day 2 (48 hours after first dose).
3 secondary outcomes
Headaches
Time frame: 0-48 hours after first dose of dexamethasone
Adverse events and side effects
Time frame: Duration of participation in study
Quality of life
Time frame: Baseline and at end of participation in study
Results and safety
The study was stopped early (reason given: premature closure due to lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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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.
Ute Bartels, MD principal investigator
The Hospital for Sick Children, Toronto Canada
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High dose dexamethasone and Low dose dexamethasone in people with Vomiting and Headache, run by The Hospital for Sick Children at 5 sites 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 12 inclusion and 8 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: stopped early, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: premature closure due to lack of accrual). Results are not available in the source record.
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?
Effectiveness of dexamethasone on vomiting (time frame: 24-48 hours after first dose of dexamethasone). 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 5 May 2016.