Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology
About this trial
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.
Eligibility criteria
Qualifiers
Women > 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Radically operated infiltrating breast cancer, pT1-T3, pN0-2, M0
Candidate to adjuvant chemotherapy that includes weekly paclitaxel 80 mg/m2 intravenous for 12 weeks [either following anthracyclines and/or in association with trastuzumab]
Disqualifiers
Evidence of metastatic disease (M1)
pT4 and/or pN3
Previous or concomitant malignancy of any other type
Previous treatment with chemotherapy, hormonal therapy or an investigational drug for any type of malignancy
Trial design
Treatments tested in this trial
- Hilotherm® Cooling treatment
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov