Cryotherapy Intervention for Docetaxel-induced Nail Toxicities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00911352
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : December 5, 2012
Information provided by (Responsible Party):
Alexandra McCarthy, Princess Alexandra Hospital, Brisbane, Australia

Brief Summary:
Between 30% and 88% of chemotherapy patients receiving docetaxel experience side effects of the hand ranging from skin and nail disfigurement, blistering, desquamation, pain, infection, and impaired treatment-related quality of life and function. Preliminary data indicate that nurse-initiated cryotherapy during treatment may lower the incidence and severity of these side effects, but several issues should be addressed before this intervention is implemented in hospital settings. These include more rigorous study design, larger sampling frames, and consideration of infection control concerns. This study will address these issues, thereby rigorously evaluating the safety and efficacy of nurse-initiated cryotherapy at Princess Alexandra Hospital.

Condition or disease Intervention/treatment Phase
Effects of Chemotherapy Device: Frozen gel glove (Elasto-Gel Mitten) Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nurse-initiated Cryotherapy Intervention for Docetaxel-induced Nail Toxicities: Case-control Study
Study Start Date : October 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Frozen gel glove (Elasto-Gel Mitten)
Cryotherapy hand
Device: Frozen gel glove (Elasto-Gel Mitten)
Gel glove is frozen for > 3 hours at -5 to -30°C prior to use. Each patient wears a triple glove set (surgical glove overlaid with cotton glove, overlaid with gel glove) on their intervention hand. Gloves are worn for duration of infusion (15 mins pre, 60 minutes intratreatment and 15 mins post) to ensure the patients' peripheries are vasoconstricted on commencement of the infusion and for enough time afterwards to ensure circulating drug does not reach the target area. Because of the duration of the infusion, more than one gel glove will be used successively (for 45 minutes each) to maintain a consistently low temperature on the hand and nails.
Other Name: Elasto-Gel Mitten

No Intervention: No frozen glove therapy
Usual care

Primary Outcome Measures :
  1. Differences in the incidence and severity of nail and skin toxicities between protected and unprotected hands [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Safety and tolerability of frozen glove treatment [ Time Frame: 12 months ]
  2. Adequacy of infection control measure added to glove protocol [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients receiving docetaxel as mono- or combination therapy
  • patients with no nail disorders at the start of treatment
  • life expectancy of at least 3 months

Exclusion Criteria:

  • patients previously treated with taxane chemotherapy
  • Raynaud's phenomenon
  • distal metastases
  • ungual pathology
  • arteriopathy
  • cold intolerance
  • peripheral neuropathy of grade 2 or higher
  • patients currently enrolled in clinical trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00911352

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Sponsors and Collaborators
Princess Alexandra Hospital, Brisbane, Australia
Principal Investigator: Alexandra McCarthy, PhD Queensland University of Technology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alexandra McCarthy, Associate Professor, Princess Alexandra Hospital, Brisbane, Australia Identifier: NCT00911352     History of Changes
Other Study ID Numbers: 2009/043
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Keywords provided by Alexandra McCarthy, Princess Alexandra Hospital, Brisbane, Australia:
Hand toxicity
Nail toxicity
Infection control

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action