Vitamin E to Prevent Mucositis in Children With Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
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|
- Objective mucositis score at 7, 10, 14, and 17 days post initiation of chemotherapy
- 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
|Study Start Date:||July 2002|
|Estimated Study Completion Date:||February 2005|
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.
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Brian M Feldman, MD, MSc||The Hospital for Sick Children|