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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422949
• Other study ID #: IEO 1974
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: August 15, 2027

Study information

• Verified date: April 2024
• Source: European Institute of Oncology
• Contact: Silvia Dellapasqua, MD
• Phone: +39 0257489970
• Email: silvia.dellapasqua[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 15, 2027
• Est. primary completion date: August 15, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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]

• Negative pregnancy test at baseline (in fertile women)

• Willing and able to sign informed consent for protocol treatment

Exclusion Criteria:

• 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

• Plans to use a chemotherapy regimen other than those specified in the inclusion criteria

• Any serious concurrent infection or any clinically significant medical illness (in particular clinically significant liver disease, clinically significant renal dysfunction, clinically significant cardiovascular disease, uncontrolled infections) which would jeopardize the ability of the patient to complete the planned therapy and follow-up

• Pre-existing motor or sensory neuropathy of any grade, for any reason

• Participation in any other clinical investigation or exposure to other investigational agents, drugs, device or procedure that may cause PN

• History of Raynaud phenomenon, either primary or secondary to autoimmune or connective tissue diseases such as systemic lupus erythematous, scleroderma, Buerger disease, Sjögren syndrome, rheumatoid arthritis, occlusive vascular disease, such as atherosclerosis, polymyositis, cold agglutinin disease or cryoglobulinemia, thyroid disorders, pulmonary hypertension

• Cold urticaria / cold contact urticaria

• Severe arterial disease

• Trophic tissue lesions

• Diabetes mellitus

• Alcohol abuse

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to the components of Hilotherm Chemo care device

• Simultaneous use of Dignicap system to prevent hair loss from chemotherapy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall incidence of grade 2 or 3 CIPN	Severity of PN evaluated using the CTCAE scale, version 5	12 months
Secondary	Incidence of withdrawal from Hilotherapy	Number of patients withdrawing Hilotherapy due to cold intolerance	12 weeks
Secondary	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)	12 months
Secondary	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)	12 months
Secondary	Pain assessment	Collection of Brief Pain Inventory (BPI) questionnaire (minimum value: 0, maximum value: 10 - higher scores mean a worse outcome)	12 months
Secondary	Technology acceptance and perception evaluation	Collection of Technology Acceptance Model Questionnaire (minimum value: 1, maximum value: 7 - higher scores mean a lower agreement with the statement)	12 months