Background. This clinical trial was developed to determine whether ocu
lar ice pack therapy would decrease 5-fluorouracil (5-FU)-induced ocul
ar toxicity. Methods. Sixty-two patients who suffered from 5-FU-induce
d ocular toxicity, and were scheduled to receive another cycle of the
chemotherapy that caused the ocular toxicity, were entered in this cli
nical trial. A randomized, crossover design was used, with patients do
cumenting their ocular toxicity by the use of daily diaries. Results.
The results from the first cycle of treatment suggested that ocular ic
e pack therapy decreased 5-FU-induced ocular toxicity (P = 0.056). The
38 evaluable patients in the crossover analyses demonstrated decrease
d ocular toxicity with ocular ice pack therapy (p=.001). The ocular ic
e pack therapy was well tolerated by most of the study participants. C
onclusion. Ocular ice pack therapy appears to lessen 5-FU-induced ocul
ar toxicity to a clinically moderate degree. Better methods for decrea
sing 5-FU-induced ocular toxicity are necessary.