Defining clinically meaningful outcomes in the evaluation of new treatments for oral mucositis: Oral mucositis patient provider advisory board

Lisa A. Bellm, Gail Cunningham, Laurie Durnell, June Eilers, Joel B. Epstein, Tom Fleming, Henry J. Fuchs, Martha Nash Haskins, Mary M. Horowitz, Paul J. Martin, Deborah B. McGuire, Kevin Mullane, Gerry Oster

Research output: Contribution to journalArticlepeer-review

43 Scopus citations

Abstract

Oral mucositis (OM)-related outcomes constituting a meaningful clinical advance in bone marrow transplant patients were considered by an interdisciplinary panel. Meaningful outcomes are essential in product development for OM, a condition without effective prevention or treatment. The most important outcomes to measure, the feasibility of measuring these in a clinical trial, and clinically meaningful differences in these outcomes were determined by the panel. Most important are reduction in oral pain and use of opioid analgesics, improvement in oral intake and quality of life, and reduction of hospitalization duration. Reduction in the severity of OM measured by an objective evaluation of oral mucosa could provide insight regarding the biologic activity of an intervention. Further data are required to define the precise relationship between reduction in visible OM and improvement in outcome. Minimally, clinical trials for OM should assess oral pain, opioid use, oral intake, and include objective assessment of OM.

Original languageEnglish (US)
Pages (from-to)793-800
Number of pages8
JournalCancer Investigation
Volume20
Issue number5-6
DOIs
StatePublished - 2002

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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