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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryocompression | Active Comparator | Patients in this group receive cryocompression for the hands. |
|
| Cryotherapy | Active Comparator | Patients in this group receive cryotherapy for the hands. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hilotherm Chemo Care | Device | Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NCV (nerve conduction velocity) | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III° | 4 years |
| CTCAE 4.03 | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III° | 4 years |
| SWME (Semmes Weinstein monofilament examination) | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III° | 4 years |
| tuning-fork-test | Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of ≥ CIPN III° | 4 years |
| EORTC QoLCIPN20 | Patient-reported outcomes (PRO) | 4 years |
| Neuro-QoL Domain for Upper Extremity (FineMotor, ADL) | Patient-reported outcomes (PRO) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| National Cancer Institute Common Toxicity Criteria version 2 | Changes of nails | 4 years |
| time frame until polyneuopathy occurs | time frame until polyneuopathy occurs whilst receiving Taxanes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Brunner | Contact | +4351250481194 | c.brunner@tirol-kliniken.at |
| Name | Affiliation | Role |
|---|---|---|
| Christine Brunner | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
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1 to 1 randomization in either cryocompression or cryotherapy of the hands
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It is an observer blinded study.
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| 4 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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