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

NCT01135550 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-05-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • C17 Council

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Ute Bartels, MD · The Hospital for Sick Children, Toronto Canada

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135550 on ClinicalTrials.gov