128
Views
49
CrossRef citations to date
0
Altmetric
Research Article

A Phase III, Randomized, Double-blind, Placebo-controlled, Multinational Trial of Iseganan for the Prevention of Oral Mucositis in Patients Receiving Stomatotoxic Chemotherapy (PROMPT-CT Trial)

, , , , , , , , , , , & show all
Pages 1165-1172 | Accepted 18 Dec 2002, Published online: 03 Aug 2009

References

  • Sonis, S. and Clark, J. (1991) "Prevention and management of oral mucositis induced by antineoplastic therapy", Oncology (Huntingt) 5, 11–18.
  • Sonis, ST., Eilers, IP., Epstein, J.B., et al. (1999) "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 85, 2103–2113.
  • Brizel, D.M., Albers, ME., Fisher, SR., et al. (1998) "Hyper-fractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer", N. Engl. J. Med. 338, 1798–1804.
  • Dreizen, S. (1978) "Stomatotoxic manifestations of cancer chemotherapy", J. Prosthet. Dent. 40, 650–655.
  • Dreizen, S., McCredie, KB., Bodey, G.P. and Keating, M.J. (1986) "Quantitative analysis of the oral complications of antileukemia chemotherapy", Oral Surg. Oral Med. Oral Pathol. 62, 650–653.
  • "Development of a staging system for chemotherapy-induced stomatitis. Western Consortium for Cancer Nursing Research". Cancer Nurs. 14 (1991) 6–12.
  • Wilkes, J.D. (1998) "Prevention and treatment of oral mucositis following cancer chemotherapy", Semin. Oncol. 25, 538–551.
  • Plevova, P. (1999) "Prevention and treatment of chemotherapy- and radiotherapy-induced oral mucositis: a review", Oral Oncol. 35, 453–470.
  • Plevova, P. (1999) "Re: Mucositis as a biological process: a new hypothesis for the development of chemotherapy-induced stomato-toxicity", Oral Oncol. 35, 225–226.
  • Elting, L.S., Bodey, G.P. and Keefe, B.H. (1992) "Septicemia and shock syndrome due to viridans streptococci: a case-control study of predisposing factors", Clin Infect. Dis. 14, 1201–1207.
  • Ruescher, T.J., Sodeifi, A., Scrivani, S.J., Kaban, L.B. and Sonis, S.T. (1998) "The impact of mucositis on alpha-hemolytic streptococcal infection in patients undergoing autologous bone marrow transplan-tation for hematologic malignancies", Cancer 82,2275–2281.
  • Rapoport, A.P., Miller Watelet, LE, Linder, T., et al. (1999) "Analysis of factors that correlate with mucositis in recipients of autologous and allogeneic stem-cell transplants", J. ClM. Oncol. 17, 2446–2453.
  • Sonis, S.T., Oster, G., Fuchs, H., et al. (2001) "Oral mucositis and the clinical and economic outcomes of hematopoietic stem-cell transplantation", J. Clin. Oncol. 19, 2201–2205.
  • Cox, J.D., Pajak, T.F., Marcial, V.A., et al. (1992) "Interruptions adversely affect local control and survival with hyperfractionated radiation therapy of carcinomas of the upper respiratory and digestive tracts. New evidence for accelerated proliferation from Radiation Therapy Oncology Group Protocol 8313", Cancer 69, 2744–2748.
  • Sonis, S.T. (1998) "Mucositis as a biological process: a new hypothesis for the development of chemotherapy-induced stomato-toxicity", Oral Oncol. 34, 39–43.
  • Sonis, S.T., Peterson, R.L., Edwards, L.J., et al. (2000) "Defining mechanisms of action of interleukin-11 on the progression of radiation-induced oral mucositis in hamsters", Oral Oncol. 36, 373–381.
  • Symonds, R.P., Mcllroy, P., Khonami, J., et al. (1996) "The reduction of radiation mucositis by selective decontamination antibiotic pastilles: a placebo-controlled double-blind trial", Br J. Cancer 74, 312–317.
  • Donnelly, J.P., Muus, P., Honevorts, A.M., Sauerwein, R.W. and De Pauw, B.E. (1993) "Failure of clindamycin to influence the course of severe oromucositis associated with streptococcal bacteraemia in allogeneic bone marrow transplant recipients", Scand. J. Infect. Dis. 25, 43–50.
  • Epstein, LB., Vickars, L., Spinelli, J. and Reece, D. (1992) "Efficacy of chlorhexidine and nystatin rinses in prevention of oral complications in leukemia and bone marrow transplantation", Oral Surg. Oral Med. Oral Pathol. 73, 682–689.
  • Rutkauskas, J.S. and Davis, J.W. (1993) "Effects of chlorhexidine during immunosuppressive chemotherapy. A preliminary report", Oral Surg. Oral Med. Oral Pathol. 76, 441–448.
  • Foote, R.L., Loprinzi, C.L., Frank, A.R., et al. (1994) "Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis", J. Clin. Oncol. 12, 2630–2633.
  • Ferretti, G.A., Ash, R.C., Brown, AT., et al. (1988) "Control of oral mucositis and candidiasis in marrow transplantation: a prospective, double-blind trial of chlorhexidine digluconate oral rinse", Bone Marrow Transplant. 3, 483–493.
  • Ferretti, G.A., Raybould, T.P., Brown, AT., et al. (1990) "Chlorhexidine prophylaxis for chemotherapy- and radiotherapy-induced stomatitis: a randomized double-blind trial", Oral Surg. Oral Med. Oral Pathol. 69, 331–338.
  • Fahrner, R.L., Dieckmann, T., Harwig, S.S., et al. (1996) "Solution structure of protegrin-1, a broad-spectrum antimicrobial peptide from porcine leukocytes", Chem. Biol. 3, 543–550.
  • Aumelas, A., Mangoni, M., Roumestand, C., et al. (1996) "Synthesis and solution structure of the antimicrobial peptide protegrin-1", Eur. J. Biochem. 237, 575–583.
  • Chen, J., Falla, T.J., Liu, H., et al. (2000) "Development of protegrins for the treatment and prevention of oral mucositis: structure—activity relationships of synthetic protegrin analogues", Biopolymers 55, 88–98.
  • Giles, EJ., Redman, R., Yazji, S. and Bellm, L. (2002) "Iseganan HC1: a novel antimicrobial agent", Expert Opin. Investig. Drugs 11, 1161–1170.
  • Mosca, D.A., Hurst, M.A., So, W., et al. (2000) "IB-367, a protegrin peptide with in vitro and in vivo activities against the microflora associated with oral mucositis", Antimicrob. Agents Chemother. 44, 1803–1808.
  • Bellm, L., Lehrer, RI. and Ganz, T. (2000) "Protegrins: new antibiotics of mammalian origin", Expert Opin. Investig. Drugs 9, 1731–1742.
  • Vesole, D. and Fuchs, H.J. (1999) "IB-367 reduces the number of days of severe oral mucositis complicating myeloablative chemotherapy", Blood 94, 154a.
  • Woo, S.B., Sonis, S.T., Monopoli, M.M. and Sonis, A.L. (1993) "A longitudinal study of oral ulcerative mucositis in bone marrow transplant recipients", Cancer 72, 1612–1617.
  • Wardley, A.M., Jayson, G.C., Swindell, R., et al. (2000) "Prospective evaluation of oral mucositis in patients receiving myeloablative conditioning regimens and haemopoietic progenitor rescue", Br. J. Haematol. 110, 292–299.
  • Peterson, D.E. (1990) "Pretreatment strategies for infection prevention in chemotherapy patients", NCI Monogr. 9, 61–71.
  • Peterson, D.E., Minah, G.E., Reynolds, MA., et al. (1990) "Effect of granulocytopenia on oral microbial relationships in patients with acute leukemia", Oral Surg. Oral Med. Oral Pathol. 70, 720–723.
  • Ferrara, J.L. (1994) "Cytokines other than growth factors in bone marrow transplantation", Curr. Opin. Oncol. 6, 127–134.
  • Bianco, J.A., Appelbaum, ER., Nemunaitis, J., et al. (1991) "Phase I-II trial of pentoxifylline for the prevention of transplant-related toxicities following bone marrow transplantation", Blood 78, 1205–1211.
  • Stiff, P. (2001) "Mucositis associated with stem cell transplantation: current status and innovative approaches to management", Bone Marrow Transplant. 27\(Suppl. 2), S3 —S11.
  • Spijkervet, F.K., van Saene, J.J., van Saene, H.K., et al. (1990) "Chlorhexidine inactivation by saliva", Oral Surg. Oral Med. Oral Pathol. 69, 444–449.
  • Spijkervet, F.K., van Saene, H.K., van Saene, J.J., et al. (1990) "Mucositis prevention by selective elimination of oral flora in irradiated head and neck cancer patients", J. Oral Pathol. Med. 19, 486–489.
  • Spijkervet, F.K., Van Saene, H.K., Van Saene, J.J., et al. (1991) "Effect of selective elimination of the oral flora on mucositis in irradiated head and neck cancer patients", J. Surg. Oncol. 46, 167–173.
  • Loury, D., Embree, JR., Steinberg, D.A., Sonis, S.T. and Fiddes, J.C. (1999) "Effect of local application of the antimicrobial peptide 1B-367 on the incidence and severity of oral mucositis in hamsters", Oral Surg. Oral Med. Oral Pathol. Oral RadioL Endod. 87, 544–551.
  • Kokryakov, V.N., Harwig, S.S., Panyutich, E.A., et al. (1993) "Protegrins: leukocyte antimicrobial peptides that combine features of corticostatic defensins and tachyplesins", FEBS Lett. 327, 231–236.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.