Abstract
The objectives were (1) to determine whether in children undergoing doxorubicin-containing
chemotherapy, topical vitamin E decreases an objective measurement of oral mucositis
compared to placebo, and (2) to assess the feasibility of an innovative trial design
in paediatric cancer, combining N-of-1 trials using Bayesian meta-analysis. We conducted a series of N-of-1, double-blinded, randomised controlled trials in children ⩾ 6 years of age receiving
repeated cycles of identical doxorubicin-containing chemotherapy. Each study cycle
was followed by topical vitamin E (800 mg) or placebo.
We enroled 16 children and 45 post chemotherapy cycles were randomised to vitamin
E (N = 22) or placebo (N = 23). There was no difference in objective mucositis scores with a mean score of 0.2
with vitamin E and 0.3 with placebo. Topical vitamin E does not reduce doxorubicin-induced
oral mucositis in children. The use of N-of-1 studies and Bayesian meta-analysis may facilitate the study of some therapies
in paediatric oncology.
Keywords
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References
- Prophylaxis and treatment of chemo- and radiotherapy-induced oral mucositis – are there new strategies?.Bone Marrow Transplant. 1999; 24: 1095-1108
- Oral complications of cancer therapy.in: De Vita Jr., V.T. Hellman S. Rosenberg S.A. Principles and practices of oncology. Lippincott-Raven, Philadelphia1993: 2385-2394
- Interventions for preventing oral mucositis for patients with cancer receiving treatment.Cochrane Database Syst Rev. 2003; : CD000978
- Adriamycin: the role of lipid peroxidation in cardiac toxicity and tumor response.Science. 1977; 197: 165-167
- Antioxidant effects of ubiquinones in microsomes and mitochondria are mediated by tocopherol recycling.Biochem Biophys Res Commun. 1990; 169: 851-857
- Effect of dose schedule of vitamin E and hydroxethylruticide on intestinal toxicity induced by adriamycin.Physiol Chem Phys Med NMR. 1986; 18: 17-24
- Treatment of mucositis with vitamin E during administration of neutropenic antineoplastic agents.Ann Med Interne (Paris). 1994; 145: 405-408
- Vitamin E in the treatment of chemotherapy-induced mucositis.Am J Med. 1992; 92: 481-484
- Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment.J Clin Epidemiol. 1997; 50: 401-410
- Bayesian methods in health technology assessment: a review.Health Technol Assess. 2000; 4: 1-130
- Comprehensive PCR-based assay for detection and species identification of human herpesviruses.J Clin Microbiol. 2000; 38: 3274-3279
- Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Mucositis Study Group.Cancer. 1999; 85: 2103-2113
World Health Organization. Handbook for reporting results of cancer treatment. Geneva; 1979.
- Generalized linear models.2nd ed. Chapman and Hall, New York1989
- Seven items were identified for inclusion when reporting a Bayesian analysis of a clinical study.J Clin Epidemiol. 2005; 58: 261-268
Article info
Publication history
Accepted:
February 12,
2007
Received in revised form:
December 6,
2006
Received:
June 30,
2006
Identification
Copyright
© 2007 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
