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

ConditionsBreast CancerNeuropathy;Peripheral
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Hilotherm® Cooling treatment

    Device

    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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Hilotherm® Cooling treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall incidence of grade 2 or 3 CIPN

Severity of PN evaluated using the CTCAE scale, version 5

Time frame
12 months

Secondary outcomes

1

Incidence of withdrawal from Hilotherapy

Number of patients withdrawing Hilotherapy due to cold intolerance

Time frame
12 weeks
2

Patients' physical, psychological and social functions evaluation

Collection of EORTC QLQ-C30 \[European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire\] (minimum value: 1, maximum value: 4 - higher scores mean a worse outcome)

Time frame
12 months
3

Side effects impact evaluation

Collection of EORTC-BR23 \[European Organization for Research and Treatment of Cancer - Breast Cancer specific Module\] (minimum value: 1, maximum value: 4 - higher scores mean a worse outcome)

Time frame
12 months
4

Pain assessment

Collection of Brief Pain Inventory (BPI) questionnaire (minimum value: 0, maximum value: 10 - higher scores mean a worse outcome)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: