A randomized trial of a nonabsorbable antibiotic lozenge given to alleviate radiation-induced mucositis.
BACKGROUND
The objective of this study was to determine whether a nonabsorbable antibiotic lozenge could alleviate radiation-induced oral mucositis.


METHODS
Patients scheduled to receive radiation therapy to more than one-third of the oral cavity mucosa were selected for the study. After stratification, patients were randomized to receive either a nonabsorbable antibiotic lozenge or a placebo. Both groups were then evaluated for mucositis by health care providers and self-report instruments.


RESULTS
Fifty-four patients were randomized to receive the antibiotic lozenge and 58 to receive the placebo. There were no substantial differences or trends in mucositis scores between the two study arms as measured by the health care providers. However, the mean patient-reported mucositis score and the duration of patient-reported Grade 3-4 mucositis were both lower in the patients randomized to the antibiotic lozenge arm (P = 0.02 and 0.007, respectively).


CONCLUSIONS
This prospective, controlled trial provides evidence to suggest that a nonabsorbable antibiotic lozenge can decrease patient-reported radiation-induced oral mucositis to a modest degree. Nonetheless, this evidence does not appear to be compelling enough to recommend this treatment as part of standard practice.
Okuno
S H
SH
Mayo Clinic, Rochester, Minnesota 55905, USA.
Foote
R L
RL
Loprinzi
C L
CL
Gulavita
S
S
Sloan
J A
JA
Earle
J
J
Novotny
P J
PJ
Burk
M
M
Frank
A R
AR
D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage*; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D002710:Chlorhexidine / Q000627:therapeutic use; D003091:Colistin / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000008:administration & dosage*; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects; D011832:Radiation Injuries / Q000188:drug therapy*; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology; D014031:Tobramycin / Q000008:administration & dosage*
D000891:Anti-Infective Agents, Local; D000666:Amphotericin B; D002710:Chlorhexidine; D014031:Tobramycin; D003091:Colistin