Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial
The Breast Nov 20, 2019
Ruddy KJ, Le-Rademacher J, Lacouture ME, et al. - Researchers undertook this prospective, randomized trial to determine whether peripheral neuropathy may be averted by cooling hands and feet with crushed ice during receipt of paclitaxel. A comparison of cryotherapy with standard care was performed in patients starting paclitaxel weekly x 12. Data from 2 previous similarly-conducted neuropathy trials were utilized to perform cross-study comparisons. Cooling of hands and feet was initiated 15 min before and ending 15 min following each paclitaxel dose, for those on cryotherapy. They estimated AUC in 39 (19 cryotherapy, 20 control) participants. Good tolerability of cryotherapy was shown, but the study arms did not differ in terms of AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel. However, less neuropathy was seen in the control arm of the current trial vs placebo arms of two past similar trials. Less neuropathy was reported in the cryotherapy arm, on comparing cryotherapy arm with the combined control arms from all three trials. The requirement of further research is highlighted given less neuropathy than expected was experienced by the control arm, although no difference in CIPN20 scores was found between the 2 study arms in the current phase II trial.
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