UICC World Cancer Congress 2006

Objective: Oral mucositis is a frequent complication to chemotherapy, the optimal prophylaxis is unknown. Methods: Previously untreated patients (pts) with GI-cancer receiving bolus 5-FU 425 mg/m2 with leucovorine 20 mg/m2 daily in five days were randomized, pending informed consent, to either chlorhexidine 0.1% 15 ml mouthrinse one minut TID for 3 wks. (regimen A), or to doubble blind placebo (normal saline with same taste additive as in A) with same dose and frequency (reg. B), or to cryotherapy with crushed ice 10 min. before to 35 min. after chemotherapy start (reg. C). Pts self-reported on severity (CTC-grading) and duration of oral mucositis. Results: Among 225 pts randomized, 206 answered the questionnaire (70, 64, and 63 pts in reg.A, reg.B, and reg.C) There were no differences between the regimens with respect to diagnoses, stage, age, gender, smoking habits, or performance status. Mucositis grade 3-4 (impaired oral nutrition/need of artificial nutrition) occurred in 13%, 33%, and 11% in regimens A, B, and C, respectively. Reg. B was significantly worse than A (p<0.01) and C (p<0.005). Median mucositis durations were A: 3 days (0-17), B: 5 (0-20), and C: 1 (0-20). Duration was significantly longer in B than in both A (p=0.035) and C (p=0.003. Conclusions: Frequency and duration of oral mucositis may be significantly improved by either prophylactic chlorhexidine or by cryotherapy. The latter is easy and inexpensive but is drug- and schedule-dependent as it cannot be used with infusional 5-FU or with chemotherapy with substantially longer half-lifes than 5-FU.