## Protocol Section
### Identification Module
**NCT ID:** NCT06422949

**Brief Title:** Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy

**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

#### Organization Study ID Info
**ID:** IEO 1974
#### Organization
**Class:** OTHER
**Full Name:** European Institute of Oncology
### Status Module
#### Completion Date
**Date:** 2027-08-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-08-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** European Institute of Oncology

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Breast Cancer

- Neuropathy;Peripheral

**Keywords:**

- Early stage breast cancer

- Paclitaxel

- Chemotherapy-induced peripheral neuropathy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cooling treatment with Hilotherm® at hands and feet level

**Intervention Names:**

- Device: Hilotherm® Cooling treatment

**Label:** Hilotherm® Cooling treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hilotherm® Cooling treatment

**Description:** 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

**Name:** Hilotherm® Cooling treatment

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Severity of PN evaluated using the CTCAE scale, version 5

**Measure:** Overall incidence of grade 2 or 3 CIPN

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Number of patients withdrawing Hilotherapy due to cold intolerance

**Measure:** Incidence of withdrawal from Hilotherapy

**Time Frame:** 12 weeks

**Description:** 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)

**Measure:** Patients' physical, psychological and social functions evaluation

**Time Frame:** 12 months

**Description:** 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)

**Measure:** Side effects impact evaluation

**Time Frame:** 12 months

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

**Measure:** Pain assessment

**Time Frame:** 12 months

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

**Measure:** Technology acceptance and perception evaluation

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** silvia.dellapasqua@ieo.it

**Name:** Silvia Dellapasqua, MD

**Phone:** +39 0257489970

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Milan

**Contacts:**

***Contact 1:***

- **Email:** silvia.dellapasqua@ieo.it

- **Name:** Silvia Dellapasqua, MD

- **Phone:** +39 0257489970

- **Role:** CONTACT

***Contact 2:***

- **Email:** mara.negri@ieo.it

- **Name:** Mara Negri

- **Phone:** +39 0257489536

- **Role:** CONTACT

**Country:** Italy

**Facility:** European Institute of Oncology

**Zip:** 20141

#### Overall Officials

**Official 1:**

**Affiliation:** European Istitute of Oncology

**Name:** Silvia Dellapasqua, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: HIGH

- As Found: Peripheral Neuropathy

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000010523

- Term: Peripheral Nervous System Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
