Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CROPSI Study A Randomized, Observer-blinded Clinical Trial Evaluating Effectiveness of Cryotherapy vs. Cryocompression for Preventing CIPN in Women Undergoing Chemotherapy

Conditions
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Chemotherapy-induced Peripheral Neuropathy, Chemotherapeutic Toxicity, Chemotherapeutic Agent Toxicity

Intervention / Treatment
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* Device: Hilotherm Chemo Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with breast cancer or other gynecological tumors planned neoadjuvant, adjuvant or palliative chemotherapy </= two lines chemotherapy as pre-therapy (adjuvant chemotherapy counts as one line) at least three cycles of chemotherapy with taxanes written consent 18 years and older Exclusion Criteria: PNP >/= 2 neuralgia metastases in bones, metastases in soft tissue (located in skin, hands or feet) Raynaud syndrome peripheral arterial ischemia hand-feet syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1 to 1 randomization in either cryocompression or cryotherapy of the hands
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryocompression<br>Patients in this group receive cryocompression for the hands. | Device: Hilotherm Chemo Care<br>* Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.<br>|
| Active Comparator: Cryotherapy<br>Patients in this group receive cryotherapy for the hands. | Device: Hilotherm Chemo Care<br>* Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Cervix Cancer, Endometrium Cancer, Ovarial Cancer, CIPN, Taxane