Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Breast Neoplasms

Peripheral Nervous System Diseases

Breast Diseases

Skin Diseases

Neuromuscular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cooling treatment with Hilotherm® at hands and feet level

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

Hilotherm® Cooling treatment

Silvia Dellapasqua, MD

Mara Negri

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.

Taxol is a very effective drug in breast cancer, but it can cause peripheral neuropathy (PN), that is damage to the nerves of the hands and feet. This toxicity can begin a few days to months after starting taxol treatment and is often dose-limiting.

Symptoms of chemotherapy-induced peripheral neuropathy (CIPN) 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 range from mild and transient symptoms to more severe and persistent symptoms. These symptoms can strongly interfere with patients' quality of life and can create difficulties in carrying out activities of daily living.

Despite numerous pharmacological approaches, no substance has proven capable of counteracting the onset of PN in patients eligible to receive chemotherapy with taxol. Some clinical studies have shown that the application of cold to the hands and feet is able to reduce the incidence of PN because the cold-induced constriction of the vessels leads to a reduction of blood flow and consequently to a reduced inflow of drug at the level of the hands and feet.

Hilotherm® is a machine that allows to keep hands and feet at a constant temperature of 10°C. 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.

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

A Study on the Efficacy and Safety of HILOTERM® Device for the Prevention of Chemotherapy-induced Peripheral Neuropathy in Early Breast Cancer Patients

Severity of PN evaluated using the CTCAE scale, version 5

Number of patients withdrawing Hilotherapy due to cold intolerance

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)

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)

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

Collection of Technology Acceptance Model Questionnaire (minimum value: 1, maximum value: 7 - higher scores mean a lower agreement with the statement)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy	NCT06422949	Breast Cancer Neuropathy;Peri...	Hilotherm® Cool...	18 Years -	European Institute of Oncology
Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy	NCT06422949	Breast Cancer Neuropathy;Peri...	Hilotherm® Cool...	18 Years -	European Institute of Oncology

Spots Global Cancer Trial Database for hilotherm® cooling treatment