title: Cryotherapy for docetaxel-induced hand and nail toxicity: randomised control trial.
abstract: OBJECTIVE
  This study investigated the efficacy and safety of cryotherapy, in the form of frozen gel gloves, in relation to docetaxel-induced hand and fingernail toxicities.
  
  
  METHODS
  After piloting with 21 patients, a consecutive series sample of patients (n=53) prescribed docetaxel every 3 weeks, for a minimum of three cycles, was enrolled in this randomised control trial. Participants acted as their own control, with the frozen gel glove worn on one randomised hand for 15 min prior to infusion, for the duration of the infusion, and for 15 min of after completion of treatment. Hand and nail toxicities were evaluated by two blinded assessors according to CTCAE.v4 criteria. To assess the potential for cross-infection of multi-use gloves, microbial culture and sensitivity swabs were taken of each glove at every tenth use.
  
  
  RESULTS
  Of the 53 participants enrolled in the main study, 21 provided evaluable data. There was a 60 % withdrawal rate due to patient discomfort with the intervention. The mean incidence and severity of toxicities in all evaluable cycles in control and intervention hands respectively were erythroderma grade 1 (5/5 %), nail discolouration grade 1 (81/67 %), nail loss grade 1 (19/19 %) and nail ridging grade 1 (57/57 %). No significant differences were determined between hand conditions in terms of time to event, nor in terms of toxicity in gloved and non-gloved hands.
  
  
  CONCLUSIONS
  While cryotherapy in the form of frozen gloves for the cutaneous toxicities associated with docetaxel is safe, its limited efficacy, patient discomfort and some logistical issues preclude its use in our clinical setting.
authors.affiliation: Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia, al.mccarthy@qut.edu.au.
authors.forename: Alexandra L
authors.initials: AL
authors.lastname: McCarthy
authors.forename: Ramon Z
authors.initials: RZ
authors.lastname: Shaban
authors.forename: Kerri
authors.initials: K
authors.lastname: Gillespie
authors.forename: Joanne
authors.initials: J
authors.lastname: Vick
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects*; D017679:Cryotherapy / Q000379:methods*; D000077143:Docetaxel; D005260:Female; D005615:Freezing; D017575:Gloves, Protective; D006225:Hand; D006801:Humans; D008297:Male; D008875:Middle Aged; D009260:Nail Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D009262:Nails / Q000187:drug effects; D009369:Neoplasms / Q000188:drug therapy; D016037:Single-Blind Method; D012871:Skin Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel