Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies.
BACKGROUND
The purpose was to evaluate prevention of oral mucositis (OM) using chlorhexidine compared with placebo and with oral cooling (cryotherapy) during fluorouracil (5-FU)-based chemotherapy in gastrointestinal (GI) cancer.


METHODS
Patients with previously untreated GI cancer receiving bolus 5-FU/leucovorin chemotherapy were randomized to chlorhexidine mouthrinse 3 times a day for 3 weeks (Arm A), double-blind placebo (normal saline) with the same dose and frequency (Arm B), or cryotherapy with crushed ice 45 minutes during chemotherapy (Arm C). Patients self-reported on severity (CTC-grading) and duration of OM.


RESULTS
Among 225 patients randomized, 206 answered the questionnaire (70, 64, and 63 patients in Arms A, B, and C, respectively) and were well balanced with respect to diagnoses, stage, age, sex, smoking habits, and performance status. Mucositis grade 3-4 occurred more frequently in Arm B (33%) than in A (13%, P< .01) and C (11%, P< .005). Duration was significantly longer in B than in both A (P= .035) and C (P= .003).


CONCLUSIONS
The frequency and duration of OM are significantly improved by prophylactic chlorhexidine and by cryotherapy. The latter is easy and inexpensive but has limited use, as it is drug- and schedule-dependent. The current study is the first double-blind randomized evaluation of prophylactic chlorhexidine in a large adult patient population with solid tumors receiving highly OM-inducing chemotherapy. A role for chlorhexidine in the prevention of OM is suggested, which should be evaluated further.
Sorensen
Jens Benn
JB
Department Oncology, Finsen Centre/National University Hospital, Copenhagen, Denmark. jens.benn.soerensen@rh.regionh.dk
Skovsgaard
Torben
T
Bork
Ellen
E
Damstrup
Lars
L
Ingeberg
Sten
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D017024:Chemotherapy, Adjuvant; D002710:Chlorhexidine / Q000627:therapeutic use*; D017679:Cryotherapy; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects*; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007053:Ice; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D013280:Stomatitis / Q000139:chemically induced / Q000628:therapy*; D016896:Treatment Outcome
D007053:Ice; D009067:Mouthwashes; D002955:Leucovorin; D002710:Chlorhexidine; D005472:Fluorouracil