Vitamin E to Prevent Mucositis in Children With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Feldman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00311116
First received: April 3, 2006
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: Vitamin E
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Serial Controlled N-of-1 Trials of Topical Vitamin E as Prophylaxis for Chemotherapy-induced Oral Mucositis in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

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

Estimated Enrollment: 16
Study Start Date: July 2002
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311116

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Brian M Feldman, MD, MSc The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Brian Feldman, Division Head, Rheumatology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00311116     History of Changes
Other Study ID Numbers: 0020010130
Study First Received: April 3, 2006
Last Updated: December 17, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Vitamin E
Cancer
pediatrics
supportive care
oral mucositis
Bayesian analysis
N-of-1 trial
prophylaxis

Additional relevant MeSH terms:
Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014