Serial controlled N-of-1 trials of topical vitamin E as prophylaxis for chemotherapy-induced oral mucositis in pediatric patients: A pilot study
By: by Lillian Sung.
Published: 2004
Language: eng
Number of pages: 122
Description: Objectives. To determine whether in children undergoing doxorubicin-containing chemotherapy, if topical vitamin E, when compared to placebo, decreases an objective measurement of oral mucositis. Methods. We conducted a series of N-of-1, double-blinded, randomized controlled trials in which children =6 years of age who were receiving repeated cycles of identical chemotherapy with at least 60 mg/m 2 of doxorubicin per cycle were randomly assigned to receive either topical vitamin E (800 mg) or placebo, 2 mL swish and spit once daily for 14 days, starting 24 to 36 hours after the completion of doxorubicin. The primary outcome was an objective mucositis score. Secondary outcomes included pain visual analogue scale (VAS) scores and modified Eastern Cooperative Oncology Group (ECOG) mucositis grade scores. Based upon feasibility, we decided a priori to enroll 16 children. This report describes the result of an interim analysis of the first 10 subjects. We planned to stop the study if there was a >95% probability of treatment efficacy at any interim analysis. Results. Between April 2001 and October 2003, 18 children were eligible to participate in this pilot study. Five families refused to participate and three children remain on study; therefore, 10 children were enrolled and are included in this analysis. There was an 82% probability that vitamin E was associated with lower objective mucositis scores and a 79% probability that vitamin E was associated with lower pain VAS scores. However, the benefit was small, with an average decrease in objective mucositis scores of only 0.2 on a scale of 0 to 5 and an average decrease in pain VAS scores of only 0.3 on a scale of 0 to 10. However, there was a 97% chance that vitamin E was associated with less morphine use. Conclusions. While topical vitamin E likely decreased doxorubicin-related mucositis, the benefit was very small according to objective and subjective measures. However, a decrease in analgesia suggests that the reduction in mucositis may be clinically meaningful. Because the results did not meet stopping criteria, we plan to accrue additional subjects.  X
Notes: Thesis (Ph.D.)--University of Toronto, 2004.

Includes bibliographical references.

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