This study's aim is to show a benefit of Cryocompression (cooling hands with additional compression of the hands) in comparison to Cryotherapy (just cooling hands) in female cancer patients (with gynecological cancer) receiving chemotherapy with taxanes. Patients who are not eligible for either cryocompression or cryotherapy are included in a control group. The expected benefits with additional compression to the cryotherapy are reduction of chemotherapy induced polyneuropathy and reduced nail changes.
In this randomized, observer blinded, monocentric study 196 patients will be included in a four years period. The patients will be 1 to 1 randomized in either cryocompression or cryotherapy. Patients who are not eligible for either cryocompression or cryotherapy will be included in the control group. Additionally every patient (excluding the control group) receives cryotherapy for the feet. Before receiving the first chemotherapy CTCAE, Semmes-Weinstein monofilament examination (SWME), vibration test for hand and feet, and nerve conduction velocity (NCV) only for hands.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
196
Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.
Medical University Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGNCV (nerve conduction velocity)
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Time frame: 4 years
CTCAE 4.03
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Time frame: 4 years
SWME (Semmes Weinstein monofilament examination)
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Time frame: 4 years
tuning-fork-test
Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III°
Time frame: 4 years
EORTC QoLCIPN20
Patient-reported outcomes (PRO)
Time frame: 4 years
Neuro-QoL Domain for Upper Extremity (FineMotor, ADL)
Patient-reported outcomes (PRO)
Time frame: 4 years
National Cancer Institute Common Toxicity Criteria version 2
Changes of nails
Time frame: 4 years
time frame until polyneuopathy occurs
time frame until polyneuopathy occurs whilst receiving Taxanes
Time frame: 4 years
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