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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04632797
Other study ID # 1224/2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 3, 2020
Est. completion date February 3, 2024

Study information

Verified date February 2020
Source Medical University Innsbruck
Contact Christine Brunner
Phone +4351250481194
Email c.brunner@tirol-kliniken.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 196
Est. completion date February 3, 2024
Est. primary completion date February 3, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hilotherm Chemo Care
Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.

Locations

Country Name City State
Austria Medical University Innsbruck Innsbruck Tirol

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary NCV (nerve conduction velocity) Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III° 4 years
Primary CTCAE 4.03 Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III° 4 years
Primary SWME (Semmes Weinstein monofilament examination) Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III° 4 years
Primary tuning-fork-test Comparison of efficacy of cryotherapy vs. cryocompression regarding occurence of = CIPN III° 4 years
Primary EORTC QoLCIPN20 Patient-reported outcomes (PRO) 4 years
Primary Neuro-QoL Domain for Upper Extremity (FineMotor, ADL) Patient-reported outcomes (PRO) 4 years
Secondary National Cancer Institute Common Toxicity Criteria version 2 Changes of nails 4 years
Secondary time frame until polyneuopathy occurs time frame until polyneuopathy occurs whilst receiving Taxanes 4 years
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