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.

Abstract

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.

• Authors: Florian Scotté, Eugeniu Banu, Jacques Medioni, Eric Levy, Christelle Ebenezer, Sandrine Marsan, Adela Banu, Jean Marc Tourani, Jean-Marie Andrieu, Stéphane Oudard
• Journal: Cancer (Cancer) Vol. 112 Issue 7 Pg. 1625-31 (Apr 01 2008) ISSN: 0008-543X [Print] United States
• PMID: 18286527 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents, Phytogenic
• Taxoids
• Docetaxel

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Phytogenic (adverse effects)
• Case-Control Studies
• Cryotherapy
• Docetaxel
• Evaluation Studies as Topic
• Female
• Follow-Up Studies
• Foot Diseases (chemically induced, prevention & control)
• Freezing
• Humans
• Male
• Middle Aged
• Nail Diseases (chemically induced, prevention & control)
• Neoplasm Invasiveness
• Neoplasms (drug therapy, pathology)
• Onycholysis (chemically induced, prevention & control)
• Taxoids (adverse effects)
• Treatment Outcome