NCT00311116

Brief Summary

The primary objective is to determine whether in children undergoing doxorubicin-containing chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective measurement of oral mucositis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Jul 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

First QC Date

April 3, 2006

Last Update Submit

December 17, 2013

Conditions

Cancer

Keywords

Vitamin ECancerpediatricssupportive careoral mucositisBayesian analysisN-of-1 trialprophylaxis

Outcome Measures

Primary Outcomes (1)

  • Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy

Secondary Outcomes (6)

  • Pain visual analogue scale

  • Difficulty swallowing visual analogue scale

  • World Health Organization mucositis grade

  • Analgesia use (topical, systemic non-narcotic or narcotic

  • Receipt of intravenous fluid, and total parenteral nutrition.

  • +1 more secondary outcomes

Interventions

Vitamin EDRUG

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis of cancer and treated at the Hospital for Sick Children, Toronto, Canada
  • planned chemotherapy includes at least two identical courses of doxorubicin-containing chemotherapy in which the dose of doxorubicin was at least 60 mg/m2 per course
  • at least 6 years of age and less than 18 years
  • lives in the Greater Toronto area

You may not qualify if:

  • allergy to vitamin E or placebo ingredients
  • child is unable to comply with topical vitamin E application
  • cild is receiving head or neck irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

NeoplasmsStomatitis

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Brian M Feldman, MD, MSc

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Rheumatology

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

July 1, 2002

Study Completion

February 1, 2005

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

CA(1)