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

NCT ID: NCT01135550

Last Updated: 2016-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Vomiting; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Standard Arm

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.

Group Type: ACTIVE_COMPARATOR

High dose dexamethasone

Intervention Type: DRUG

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.

Control Arm

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.

Group Type: ACTIVE_COMPARATOR

Low dose dexamethasone

Intervention Type: DRUG

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.

Interventions

High dose dexamethasone

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

Low dose dexamethasone

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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 who were not enrolled on Dexamethasone study prior to start of radiation therapy.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C17 Council

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Ute Bartels

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ute Bartels, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

McMaster University Hospital

Hamilton, Ontario, Canada

Children's Hospital of Western Ontario

London, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000014713

Identifier Type: -

Identifier Source: org_study_id