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

NCT06422949 | Not Yet Recruiting

• 1 other identifier: IEO 1974
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Neuropathy;Peripheral

Keywords

Early stage breast cancer; Paclitaxel; Chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Overall incidence of grade 2 or 3 CIPN

  Severity of PN evaluated using the CTCAE scale, version 5

  12 months

Secondary Outcomes (5)

• Incidence of withdrawal from Hilotherapy

  12 weeks

• Patients' physical, psychological and social functions evaluation

  12 months

• Side effects impact evaluation

  12 months

• Pain assessment

  12 months

• Technology acceptance and perception evaluation

  12 months

Study Arms (1)

Hilotherm® Cooling treatment

EXPERIMENTAL

Cooling treatment with Hilotherm® at hands and feet level

Device: Hilotherm® Cooling treatment

Interventions

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

Hilotherm® Cooling treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Neuritis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Silvia Dellapasqua, MD

  European Istitute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Dellapasqua, MD

CONTACT

+39 0257489970; silvia.dellapasqua@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: May 31, 2024

Record last verified: 2024-04

Locations

IT (1)