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Vitamin E to Prevent Mucositis in Children With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311116
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : December 18, 2013
Information provided by (Responsible Party):
Brian Feldman, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Vitamin E Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : July 2002
Study Completion Date : February 2005

Primary Outcome Measures :
  1. Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy

Secondary Outcome Measures :
  1. Pain visual analogue scale
  2. Difficulty swallowing visual analogue scale
  3. World Health Organization mucositis grade
  4. Analgesia use (topical, systemic non-narcotic or narcotic
  5. Receipt of intravenous fluid, and total parenteral nutrition.
  6. Chemotherapy decrements or delays due to mucositis

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311116

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

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Responsible Party: Brian Feldman, Division Head, Rheumatology, The Hospital for Sick Children Identifier: NCT00311116     History of Changes
Other Study ID Numbers: 0020010130
First Posted: April 5, 2006    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013
Keywords provided by Brian Feldman, The Hospital for Sick Children:
Vitamin E
supportive care
oral mucositis
Bayesian analysis
N-of-1 trial
Additional relevant MeSH terms:
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Mouth Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomatognathic Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents