1. 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).
- Author
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Giles FJ, Miller CB, Hurd DD, Wingard JR, Fleming TR, Sonis ST, Bradford WZ, Pulliam JG, Anaissie EJ, Beveridge RA, Brunvand MM, and Martin PJ
- Subjects
- Adolescent, Adult, Aged, Antimicrobial Cationic Peptides, Antineoplastic Agents adverse effects, Child, Double-Blind Method, Humans, International Agencies, Middle Aged, Mouth Mucosa drug effects, Neoplasms drug therapy, Peptides, Placebos, Stomatitis chemically induced, Stomatitis etiology, Anti-Infective Agents therapeutic use, Proteins therapeutic use, Stomatitis prevention & control
- Abstract
Microfloral invasion and colonization of oral cavity mucosal tissues 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 iseganan in preventing UOM after stomatotoxic therapy. Patients received an oral rinse of iseganan 9 mg or placebo, swished/swallowed 6 times daily, starting with stomatotoxic therapy and continuing for 21-28 days. One hundred sixty three and 160 patients, respectively, were randomized to receive iseganan or placebo. One hundred and two patients (32%) were affected by a drug dispensing error, caused by a flawed computerized allocation system. Among all 323 patients, analyzed according to randomization assignment, 43% and 33% of iseganan and placebo patients, respectively, did not develop UOM (P = 0.067). On an 11-point scale, iseganan patients experienced less mouth pain (3.0 and 3.8 (P = 0.041), throat pain (3.8 and 4.6 (P = 0.048)), and difficulty swallowing (3.9 and 4.7 (P = 0.074)), compared to placebo patients. On the 5-point NCI CTC scale, iseganan patients experienced lower stomatitis scores (1.6 and 2.0 (P = 0.0131). Iseganan was well tolerated; no systemic absorption was detected. Iseganan is safe and may be effective in reducing UOM and its clinical sequelae.
- Published
- 2003
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