The antimicrobial effect of Iseganan HCl oral solution in patients receiving stomatotoxic chemotherapy: Analysis from a multicenter, double-blind, placebo-controlled, randomized, phase III clinical trial

Sharon Elad*, Joel B. Epstein, Judith Raber-Durlacher, Peter Donnelly, Jacob Strahilevitz

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

32 Scopus citations

Abstract

Background: Cytotoxic chemotherapy induces changes in the oral microflora that may cause oral and systemic infections in myelosuppressed cancer patients. These complications prompted us to assess the antimicrobial activity of a topical Iseganan HCl mouthwash vs. placebo on the aerobic and facultatively anaerobic oral flora in these patients. Methods: Two hundred and twenty-five chemotherapy patients were recruited into a randomized, double-blind, placebo-controlled trial, conducted at multiple centers. The study compared the antimicrobial efficacy of Iseganan HCl vs. placebo (95% of the Iseganan and 97% of the control group received myeloablative chemotherapy). Iseganan HCl 9mg/3ml was administered as a swish and swallow solution, six times daily for 21-28days. Microbial cultures were made before and after the daily Iseganan mouth rinse on the first and final days of chemotherapy. Results: The reduction in total microbial load after the first day of treatment was statistically significant (1.59 vs. 0.18 log10CFU for the Iseganan HCl and placebo groups, respectively, P<0.0001). Iseganan HCl rinse had a cumulative effect demonstrated by the significant difference between the two groups on the last day of the study (i.e. completion of Iseganan daily treatment) (P<0.05). The reduction was mainly due to decreased densities of viridans streptococci, non-hemolytic streptococci, and yeasts. The minimal inhibitory concentration (MIC) of Iseganan HCl remained the same throughout the course of treatment. Conclusions: Topical Iseganan HCl significantly reduces the total oral aerobic bacterial, streptococcal, and yeast load. Its potential as an oral antimicrobial agent in preventing these types of infections is clear.

Original languageAmerican English
Pages (from-to)229-234
Number of pages6
JournalJournal of Oral Pathology and Medicine
Volume41
Issue number3
DOIs
StatePublished - Mar 2012
Externally publishedYes

Keywords

  • Antifungal
  • Antimicrobial
  • Isegenan
  • Oral
  • Topical

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