Breast CancerNCT06422949
Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy
A study testing Hilotherm® Cooling treatment in people with Breast Cancer and Neuropathy;Peripheral, run by European Institute of Oncology at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neuropathy;Peripheral
- What is being tested?
- Hilotherm® Cooling treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2024to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
European Institute of Oncology
Milan, 20141
Silvia Dellapasqua, MD, +39 0257489970, silvia.dellapasqua@ieo.it
Mara Negri, +39 0257489536, mara.negri@ieo.it
About this study
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
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.
Read the 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
- Breast Cancer, Neuropathy;Peripheral
- Being tested
- Hilotherm® Cooling treatment
- Keywords
- Early stage breast cancer, Paclitaxel, Chemotherapy-induced peripheral neuropathy
- Medical subject headings
- Breast Neoplasms, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hilotherm® Cooling treatmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Hilotherm® Cooling treatment | Experimental | Cooling treatment with Hilotherm® at hands and feet level Receives: Device: Hilotherm® Cooling treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of grade 2 or 3 CIPN
Severity of PN evaluated using the CTCAE scale, version 5
Measured: 12 months
Secondary outcomes (5)
Incidence of withdrawal from Hilotherapy
Number of patients withdrawing Hilotherapy due to cold intolerance
Measured: 12 weeks
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)
Measured: 12 months
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)
Measured: 12 months
Pain assessment
Collection of Brief Pain Inventory (BPI) questionnaire (minimum value: 0, maximum value: 10 - higher scores mean a worse outcome)
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Dellapasqua, MD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422949
- Sponsor's protocol ID
- IEO 1974
- Status last verified
- Apr 2024
- First submitted
- 15 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06422949
- Acronym / sponsor ID
- IEO 1974
- Conditions
- Breast Cancer, Neuropathy;Peripheral
- Keywords
- Early stage breast cancer, Paclitaxel, Chemotherapy-induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hilotherm® Cooling treatment | Experimental | Device: Hilotherm® Cooling treatmentCooling treatment with Hilotherm® at hands and feet level |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hilotherm® Cooling treatmentPatient 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 | Device | Hilotherm® Cooling treatment |
Primary outcome
Overall incidence of grade 2 or 3 CIPN
Time frame: 12 months
Severity of PN evaluated using the CTCAE scale, version 5
5 secondary outcomes
Incidence of withdrawal from Hilotherapy
Time frame: 12 weeks
Patients' physical, psychological and social functions evaluation
Time frame: 12 months
Side effects impact evaluation
Time frame: 12 months
Pain assessment
Time frame: 12 months
Technology acceptance and perception evaluation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Dellapasqua, MD principal investigator
European Istitute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hilotherm® Cooling treatment in people with Breast Cancer and Neuropathy;Peripheral, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Dellapasqua, MD (+39 0257489970, silvia.dellapasqua@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of grade 2 or 3 CIPN (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.