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Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy

NCT06422949 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-31

No results posted yet for this study

Summary

Taxol is a very effective drug in breast cancer, but it can cause peripheral neuropathy (PN). This toxicity is often dose-limiting. Symptoms of PN usually improve after taxol discontinuation, but \>80% of affected women experience symptoms 1-3 years after treatment stop. The intensity, the duration and the type of symptoms related to PN are very different and they can strongly interfere with patients' quality of life.

The application of cold to the hands and feet seems to be able to reduce the incidence of PN. Hilotherm® is a machine that allows to cool hands and feet. The aim of this study is to verify whether the use of Hilotherm® is able to reduce the incidence of moderate and severe PN and to evaluate the tolerability of Hilotherm® and its impact on quality of life.

Conditions

Interventions

DEVICE

Hilotherm® Cooling treatment

Patient will receive cooling treatment with Hilotherm® at hands and feet level from half an hour before taxol treatment start until half an hour after treatment end

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Silvia Dellapasqua, MD · European Istitute of Oncology

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2027-08-15
Completion
2027-08-15

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06422949 on ClinicalTrials.gov