Vitamin E to Prevent Mucositis in Children With Cancer
Primary Purpose
Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Vitamin E
Sponsored by
About this trial
This is an interventional prevention trial for Cancer focused on measuring Vitamin E, Cancer, pediatrics, supportive care, oral mucositis, Bayesian analysis, N-of-1 trial, prophylaxis
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: allergy to vitamin E or placebo ingredients child is unable to comply with topical vitamin E application cild is receiving head or neck irradiation
Sites / Locations
- The Hospital for Sick Children
Outcomes
Primary Outcome Measures
Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy
Secondary Outcome Measures
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.
Chemotherapy decrements or delays due to mucositis
Full Information
NCT ID
NCT00311116
First Posted
April 3, 2006
Last Updated
December 17, 2013
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT00311116
Brief Title
Vitamin E to Prevent Mucositis in Children With Cancer
Official Title
Serial Controlled N-of-1 Trials of Topical Vitamin E as Prophylaxis for Chemotherapy-induced Oral Mucositis in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
5. Study Description
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.
Detailed Description
Oral mucositis is a common consequence of chemotherapy and is an important sequela of cancer therapy because it is painful and affects quality of life, may lead to hospitalization for hydration or pain control, and provides a portal of entry for oral microflora. In addition, oral mucositis has become a major dose-limiting toxicity and consequently, may limit delivery of anti-cancer therapy.
Despite the frequency of mucositis, there are no feasible therapies proven to be successful in preventing mucositis in children. Vitamin E is a fat-soluble essential vitamin that may protect against doxorubicin-induced oral mucositis through its anti-oxidant properties.
In this study, we will examine the efficacy of topical vitamin E as prophylaxis against chemotherapy-induced mucositis with a novel methodology appropriate for the study of rare conditions, namely combining N-of-1 trials using Bayesian meta-analysis.
The primary outcome is an objective mucositis score measured on days 7, 10, 14 and 17. Secondary outcomes included daily pain and swallowing visual analogue scale scores, and World Health Organization mucositis scores collected on days 5 to 20.
Comparisons: Objective and subjective mucositis scores will be compared in cycles associated with topical vitamin E versus cycles associated with placebo administration. We will use repeated measures analysis within a Bayesian framework in order to conduct this comparison.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Vitamin E, Cancer, pediatrics, supportive care, oral mucositis, Bayesian analysis, N-of-1 trial, prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Primary Outcome Measure Information:
Title
Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy
Secondary Outcome Measure Information:
Title
Pain visual analogue scale
Title
Difficulty swallowing visual analogue scale
Title
World Health Organization mucositis grade
Title
Analgesia use (topical, systemic non-narcotic or narcotic
Title
Receipt of intravenous fluid, and total parenteral nutrition.
Title
Chemotherapy decrements or delays due to mucositis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
allergy to vitamin E or placebo ingredients
child is unable to comply with topical vitamin E application
cild is receiving head or neck irradiation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Feldman, MD, MSc
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Vitamin E to Prevent Mucositis in Children With Cancer
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