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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00911352




Registration number
NCT00911352
Ethics application status
Date submitted
29/05/2009
Date registered
1/06/2009
Date last updated
5/12/2012

Titles & IDs
Public title
Cryotherapy Intervention for Docetaxel-induced Nail Toxicities
Scientific title
Nurse-initiated Cryotherapy Intervention for Docetaxel-induced Nail Toxicities: Case-control Study
Secondary ID [1] 0 0
2009/043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effects of Chemotherapy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Frozen gel glove (Elasto-Gel Mitten)

Experimental: Frozen gel glove (Elasto-Gel Mitten) - Cryotherapy hand

No Intervention: No frozen glove therapy - Usual care


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Differences in the incidence and severity of nail and skin toxicities between protected and unprotected hands
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Safety and tolerability of frozen glove treatment
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Adequacy of infection control measure added to glove protocol
Timepoint [2] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Other
Name
Princess Alexandra Hospital, Brisbane, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00911352
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexandra McCarthy, PhD
Address 0 0
Queensland University of Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries