Cryotherapy Intervention for Docetaxel-induced Nail Toxicities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexandra McCarthy, Princess Alexandra Hospital, Brisbane, Australia
ClinicalTrials.gov Identifier:
NCT00911352
First received: May 29, 2009
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Effects of Chemotherapy
Device: Frozen gel glove (Elasto-Gel Mitten)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nurse-initiated Cryotherapy Intervention for Docetaxel-induced Nail Toxicities: Case-control Study

Resource links provided by NLM:


Further study details as provided by Princess Alexandra Hospital, Brisbane, Australia:

Primary Outcome Measures:
  • Differences in the incidence and severity of nail and skin toxicities between protected and unprotected hands [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of frozen glove treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Adequacy of infection control measure added to glove protocol [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911352

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

No publications provided by Princess Alexandra Hospital, Brisbane, Australia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexandra McCarthy, Associate Professor, Princess Alexandra Hospital, Brisbane, Australia
ClinicalTrials.gov Identifier: NCT00911352     History of Changes
Other Study ID Numbers: 2009/043
Study First Received: May 29, 2009
Last Updated: December 3, 2012
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014