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

NCT01135550 | Terminated Phase 3

• 1 other identifier: 1000014713
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

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.

Conditions

Vomiting; Headache

Keywords

Pediatrics; Vomiting; Headache; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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).

  24-48 hours after first dose of dexamethasone

Secondary Outcomes (3)

• Headaches

  0-48 hours after first dose of dexamethasone

• Adverse events and side effects

  Duration of participation in study

• Quality of life

  Baseline and at end of participation in study

Study Arms (2)

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.

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.

Drug: Low dose dexamethasone

Interventions

High dose dexamethasone 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.

Standard Arm

Low dose dexamethasone 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.

Control Arm

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• C17 Council: collaborator

Study Sites (5)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

McMaster University Hospital

Hamilton, Ontario, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Vomiting; Headache

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ute Bartels, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

CA (5)