An interventional study of Hilotherm Chemo Care in Chemotherapy-induced Peripheral Neuropathy, Chemotherapeutic Toxicity and Chemotherapeutic Agent Toxicity, sponsored by Medical University Innsbruck. Status unknown at 1 site in Austria. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Medical University Innsbruck · Not applicable, Interventional, and Prevention
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 196 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group receive cryocompression for the hands.
Device: Hilotherm Chemo Care
Patients in this group receive cryotherapy for the hands.
Device: Hilotherm Chemo Care
Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.
NCV (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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
Medical University Innsbruck