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A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy.

Publication ,  Journal Article
Giles, FJ; Rodriguez, R; Weisdorf, D; Wingard, JR; Martin, PJ; Fleming, TR; Goldberg, SL; Anaissie, EJ; Bolwell, BJ; Chao, NJ; Shea, TC ...
Published in: Leuk Res
June 2004

The invasion and colonization of oral cavity mucosal tissues by microflora may contribute to the pathophysiology of ulcerative oral mucositis (UOM). Iseganan is an analog of protegrin-1, a naturally occurring peptide with broad-spectrum microbicidal activity. A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of iseganan in preventing UOM after stomatotoxic therapy. Patients received an oral rinse, consisting of iseganan 9mg or placebo, to be swished/swallowed six times daily, starting with stomatotoxic therapy and continuing up to 21 days. Patients were assessed for stomatitis and UOM, and administered a questionnaire evaluating mouth pain and difficulty swallowing thrice weekly. The primary study efficacy endpoint was the proportion of patients who did not have peak stomatitis NCI-CTC grade >or=2. Between November 2001 and June 2002, 502 patients were randomized to receive iseganan (251) or placebo (251). Equivalent numbers of patients in both cohorts received bone marrow or peripheral blood allogeneic or autologous stem cell transplantation (SCT). Forty-three percent and 37% of iseganan and placebo patients, respectively, did not have peak stomatitis grade =2 (P = 0.182). There was no significant difference between the cohorts in stomatitis severity, incidence of UOM, peak mouth pain, peak difficulty swallowing, amount of opiate analgesics used, or adverse event type or incidence. A major impact of Iseganan on reducing stomatitis, UOM, or its clinical sequelae in patients receiving stomatotoxic therapy was not detected on this study.

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Published In

Leuk Res

DOI

ISSN

0145-2126

Publication Date

June 2004

Volume

28

Issue

6

Start / End Page

559 / 565

Location

England

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Homologous
  • Surveys and Questionnaires
  • Stomatitis
  • Stem Cell Transplantation
  • Proteins
  • Placebos
  • Peptides
  • Neoplasms
  • Mouth Mucosa
 

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Giles, F. J., Rodriguez, R., Weisdorf, D., Wingard, J. R., Martin, P. J., Fleming, T. R., … Hurd, D. D. (2004). A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy. Leuk Res, 28(6), 559–565. https://doi.org/10.1016/j.leukres.2003.10.021
Giles, Francis J., Roberto Rodriguez, Daniel Weisdorf, John R. Wingard, Paul J. Martin, Thomas R. Fleming, Stuart L. Goldberg, et al. “A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy.Leuk Res 28, no. 6 (June 2004): 559–65. https://doi.org/10.1016/j.leukres.2003.10.021.
Giles FJ, Rodriguez R, Weisdorf D, Wingard JR, Martin PJ, Fleming TR, et al. A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy. Leuk Res. 2004 Jun;28(6):559–65.
Giles, Francis J., et al. “A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy.Leuk Res, vol. 28, no. 6, June 2004, pp. 559–65. Pubmed, doi:10.1016/j.leukres.2003.10.021.
Giles FJ, Rodriguez R, Weisdorf D, Wingard JR, Martin PJ, Fleming TR, Goldberg SL, Anaissie EJ, Bolwell BJ, Chao NJ, Shea TC, Brunvand MM, Vaughan W, Petersen F, Schubert M, Lazarus HM, Maziarz RT, Silverman M, Beveridge RA, Redman R, Pulliam JG, Devitt-Risse P, Fuchs HJ, Hurd DD. A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy. Leuk Res. 2004 Jun;28(6):559–565.
Journal cover image

Published In

Leuk Res

DOI

ISSN

0145-2126

Publication Date

June 2004

Volume

28

Issue

6

Start / End Page

559 / 565

Location

England

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Homologous
  • Surveys and Questionnaires
  • Stomatitis
  • Stem Cell Transplantation
  • Proteins
  • Placebos
  • Peptides
  • Neoplasms
  • Mouth Mucosa