Scotte, F., Banu, E., Medioni, J., Levy, E., Ebenezer, C., Marsan, S., . . . Oudard, S. (2008). Matched case-control phase 2 study to evaluate the use of a frozen sock to prevent docetaxel-induced onycholysis and cutaneous toxicity of the foot. Cancer, 112, 1625–1631.
To assess the efficacy and safety of cold therapy in the prevention of docetaxel-induced onycholysis and skin toxicity of the foot
Patients wore an Elasto-Gel (Akromed, France) flexible frozen sock (FS) containing glycerin, which has thermal properties that allow its use in cold or hot therapies. The FS covered participants' right foot up to the ankle. The FS was refrigerated for at least three hours at –250 C to –300 C. The FS was worn at each docetaxel infusion for a total of 90 minutes (from 15 minutes before administration to 15 minutes postdocetaxel hourly infusion). Two FSs were used successively (45 minutes each) to maintain coolness. The left foot was not protected and acted as the control.
Prospective, convenience, case-controlled, phase II study of 50 consecutive patients (unblinded)
The FSs led to a significant reduction in nail toxicity with 0% versus 21% (p = 0.002). Overall skin toxicity existed in 2% of FS-protected feet but only 6% of others, which was insignificant (p = 0.18). Time until nail toxicity occurrence for an unprotected foot was associated with the number of cycles (HR of 0.36, 95% confidence interval [0.17, 0.77], p = 0.008). Fifty-eight percent were satisfied and even very satisfied (19%) with the FS protection. Only 2% of patients were dissatisfied because of FS-related cold intolerance.
Cold therapy using FSs significantly reduced the incidence of docetaxel-induced foot nail toxicity, as previously demonstrated on hands using frozen gloves.
Greater than half (58%) the patients were satisfied with wearing the FS, with 19% being very satisfied. This would assist nursing education for the intervention. This intervention is easy to apply with no major side effects. Because the use of FSs did not significantly affect skin toxicity, a study using a type of FS that only covers toes and nails should be tested. This intervention should also be tested with patients receiving other chemotherapy agents associated with nail and skin toxicities.