Cryotherapy Intervention for Docetaxel-induced Nail Toxicities

NCT00911352 | Completed Phase 2

• 1 other identifier: 2009/043
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Effects of Chemotherapy

Keywords

Cryotherapy; Hand toxicity; Nail toxicity; Infection control

Outcome Measures

Primary Outcomes (1)

• Differences in the incidence and severity of nail and skin toxicities between protected and unprotected hands

  12 months

Secondary Outcomes (2)

• Safety and tolerability of frozen glove treatment

  12 months

• Adequacy of infection control measure added to glove protocol

  12 months

Study Arms (2)

Frozen gel glove (Elasto-Gel Mitten)

EXPERIMENTAL

Cryotherapy hand

Device: Frozen gel glove (Elasto-Gel Mitten)

No frozen glove therapy

NO INTERVENTION

Usual care

Interventions

Frozen gel glove (Elasto-Gel Mitten) DEVICE

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.

Also known as: Elasto-Gel Mitten

Frozen gel glove (Elasto-Gel Mitten)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Princess Alexandra Hospital, Brisbane, Australia: lead

Study Sites (1)

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Related Publications (1)

• McCarthy AL, Shaban RZ, Gillespie K, Vick J. Cryotherapy for docetaxel-induced hand and nail toxicity: randomised control trial. Support Care Cancer. 2014 May;22(5):1375-83. doi: 10.1007/s00520-013-2095-x. Epub 2013 Dec 22.

  PMID: 24362908 DERIVED

Study Officials

• Alexandra McCarthy, PhD

  Queensland University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 1, 2009
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

AU (1)