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Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation

Primary Purpose

Vomiting, Headache

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
High dose dexamethasone
Low dose dexamethasone
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vomiting focused on measuring Pediatrics, Vomiting, Headache, Radiation Therapy

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Enrolment:

  • 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.
  • 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.

Exclusion Criteria for Enrolment:

  • 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.

Sites / Locations

  • Alberta Children's Hospital
  • BC Children's Hospital
  • McMaster University Hospital
  • Children's Hospital of Western Ontario
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Adverse events and side effects
These will be described with numbers, type and frequencies for the duration of the subjects participation in the 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).

Full Information

First Posted
June 1, 2010
Last Updated
May 3, 2016
Sponsor
The Hospital for Sick Children
Collaborators
C17 Council
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1. Study Identification

Unique Protocol Identification Number
NCT01135550
Brief Title
Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
premature closure due to lack of accrual
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
C17 Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Headache
Keywords
Pediatrics, Vomiting, Headache, Radiation Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
High dose dexamethasone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Low dose dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of dexamethasone on vomiting
Description
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).
Time Frame
24-48 hours after first dose of dexamethasone
Secondary Outcome Measure Information:
Title
Headaches
Description
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).
Time Frame
0-48 hours after first dose of dexamethasone
Title
Adverse events and side effects
Description
These will be described with numbers, type and frequencies for the duration of the subjects participation in the study.
Time Frame
Duration of participation in study
Title
Quality of life
Description
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).
Time Frame
Baseline and at end of participation in study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Enrolment: 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. 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. Exclusion Criteria for Enrolment: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ute Bartels, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
McMaster University Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation

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