The trial will be preceded by a pilot phase study in 5 patients. This will then be followed by the randomized 1:1 phase II trial testing the utility of regional cryotherapy in preventing or reducing paclitaxel-induced peripheral neuropathy compared to no treatment. It is hypothesized that cryotherapy causes regional blood vessel constriction and decreases the paclitaxel exposure to the distal epithelial nerve fibres, thus resulting in decreased nerve damage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
51
Elasto-Gel™ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies.
80mg/m\^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles
National Cancer Centre Singapore
Singapore, Singapore
RECRUITINGProportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 3 months after baseline
PNQ scale ranges from scores A to E; with scoring of A being not affected neuropathy, and E with the worst neuropathy
Time frame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 15 months after baseline
Time frame: From commencement to completion of primary chemotherapy - estimated 15 months
Proportion of patients with lower sensory velocity and amplitudes (based on nerve conduction tests), in cryotherapy arm versus controlled arm, at 15 months after baseline
Time frame: From commencement to completion of primary chemotherapy - estimated 15 months
Incidence of adverse events, in cryotherapy arm versus controlled arm
Time frame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Proportion of patients reported intolerance and require cessation of therapies, in cryotherapy arm versus controlled arm
Time frame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
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