Vitamin E to Prevent Mucositis in Children With Cancer

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT00311116

Collaborator

(none)

Enrollment

Location

31.1

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2002

Study Completion Date :

Feb 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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