Nurse-initiated Cryotherapy Intervention for Docetaxel-induced Nail Toxicities: Case-control Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- Differences in the incidence and severity of nail and skin toxicities between protected and unprotected hands
Study Overview
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.
Detailed Description
Research problem:
Internationally, cryotherapy for docetaxel-induced nail and skin toxicities of the hand has become a popular primary treatment. Yet there is little evidence beyond one Phase II, non-randomised, (n=45) study to support such widespread use. There are also unanswered concerns relating to the potential of this treatment to cross-infect patients at risk of immunocompromise. This phase II case-control study extends previous work to address sample size concerns, enhance methodological rigour and add new evidence with respect to infection control, prior to its possible implementation at Princess Alexandra Hospital (PAH).
Hypothesis/questions/outcomes:
Aim: This study will investigate the utility, efficacy and safety of cryotherapy, in the form of frozen gel gloves, with respect to the prevention of docetaxel-induced nail and skin toxicities in cancer patients.
Hypotheses:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Differences in the incidence and severity of nail and skin toxicities between protected and unprotected hands
Time Frame: 12 months
Secondary Outcomes
- Safety and tolerability of frozen glove treatment(12 months)
- Adequacy of infection control measure added to glove protocol(12 months)
Investigators
Alexandra McCarthy
Associate Professor
Princess Alexandra Hospital, Brisbane, Australia