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.
BACKGROUND
Onycholysis occurs in approximately 30% of patients treated with docetaxel. The efficacy and safety of an Elasto-Gel frozen sock (FS) was investigated for the prevention of docetaxel-induced nail and skin toxicity of the feet.


METHODS
Patients receiving docetaxel at a dose of 70 to 100 mg/m(2) every 3 weeks were eligible for this matched case-control study. Each patient wore an FS for 90 minutes on the right foot. The unprotected left foot acted as control. Nail and skin toxicities were assessed using National Cancer Institute Common Toxicity Criteria (version 3) and compared using a 2-sample Wilcoxon matched-pairs rank test adjusted for tied values.


RESULTS
Fifty consecutive patients were included between April 2005 and January 2007. Nail toxicity was significantly lower in the FS-protected foot compared with the control foot (grade 0: 100% versus 79%; and grade 1 and 2: 0% versus 21%, respectively) (P= .002). Skin toxicity was grade 0: 98% versus 94%; and grade 1 and 2: 2% versus 6% in the FS-protected and the control feet, respectively. The median times until toxicity occurrence were not found to differ significantly between the groups. One patient experienced discomfort because of cold intolerance.


CONCLUSIONS
Cold therapy using FS significantly reduced the incidence of docetaxel-induced foot nail toxicity, as previously demonstrated using frozen gloves for the hands.
Scotté
Florian
F
Department of Medical Oncology, Georges Pompidou European Hospital, Paris, France. florian,scotte@egp.aphp.fr
Banu
Eugeniu
E
Medioni
Jacques
J
Levy
Eric
E
Ebenezer
Christelle
C
Marsan
Sandrine
S
Banu
Adela
A
Tourani
Jean Marc
JM
Andrieu
Jean-Marie
JM
Oudard
Stéphane
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects*; D016022:Case-Control Studies; D017679:Cryotherapy; D000077143:Docetaxel; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D005534:Foot Diseases / Q000139:chemically induced / Q000517:prevention & control*; D005615:Freezing; D006801:Humans; D008297:Male; D008875:Middle Aged; D009260:Nail Diseases / Q000139:chemically induced / Q000517:prevention & control*; D009361:Neoplasm Invasiveness; D009369:Neoplasms / Q000188:drug therapy / Q000473:pathology; D054039:Onycholysis / Q000139:chemically induced / Q000517:prevention & control*; D043823:Taxoids / Q000009:adverse effects*; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel