CIPN - Chemotherapy-Induced Peripheral NeuropathyNCT07780955
Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy
A study testing Cryotherapy in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and CIPN, run by Azienda Sanitaria dell'Alto Adige at 4 sites in Italy.
Trial summary
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), which may negatively affect quality of life and lead to treatment modifications or discontinuation. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN, CIPN in Adjuvant Breast Cancer Patients
- What is being tested?
- Cryotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 4 sitesItaly
- Study dates
- 11 Oct 2025to Oct 2028
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paclitaxel weekly (80 mg/m2) at least 12 cycles (in adjuvant, neo-adjuvant setting or metastatic setting following the present schemes: TH (Paclitaxel, Trastuzumab), AC-TH (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab), AC-THP (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab, Pertuzumab), AC-T (Doxorubicin, Cyclophosphamide, Paclitaxel)
- Eastern Cooperative Oncology Group Performance Status (ECOG) < 2
- Female sex
- Age: 18-90 years
- written informed consent
Who cannot join
- pre-existing motor/sensitive peripheral neuropathy
- diabetes
- Endocrinopathies
- presence of brain, bone, soft tissue, or skin of hands or feet metastases
- Raynaud's syndrome
- Peripheral arterial disease
- hand and foot syndrome
- any other reason that may hamper the data collection as assessed by the examiner
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Not yet recruiting
Ospedale di Bolzano
Bolzano, Bolzano
Luca Tondulli, MD, +39 0471438953, oncologia.bz@asdaa.it
- Recruiting
Ospedale di Bressanone
Brixen, Bolzano, 39042
Mattia Bergamo, MD, +390472812568, mattia.bergamo@sabes.it
Mattia Bergamo, MD
- Recruiting
Ospedale di Brunico
Bruneck, Bolzano, 39031
Christoph Leitner, MD, +39 0474581120, onkologia.bk@asdaa.it
- Recruiting
Ospedale di Merano
Merano, Bolzano
Martin Erl, MD, +39 0473263280, day.hospital.me@sabes.it
About this study
Official title: Multimodal Evaluation of Cryotherapy to Reduce Incidence of Chemotherapy-induced Peripheral Neurotoxicity in Breast Cancer Patients Treated With Paclitaxel Weekly
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), which may negatively affect quality of life and lead to treatment modifications or discontinuation. The aim of this clinical trial is to evaluate whether acral cryotherapy during chemotherapy administration can reduce the incidence and severity of CIPN.
Participants receiving cryotherapy will be compared with participants receiving standard care without cryotherapy. During chemotherapy treatment and throughout the first year of follow-up, all participants will undergo serial evaluations of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and blood tests. In addition to routine laboratory testing, extra blood samples will be collected at two time points to assess biomarkers of nerve damage.
Read the detailed description
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), a frequent and potentially dose-limiting toxicity caused by damage to peripheral nerves. Symptoms of CIPN may persist long after treatment completion and can significantly impair quality of life and daily functioning.
The application of cold to the hands and feet during chemotherapy administration may reduce the incidence and severity of CIPN by decreasing local blood flow and limiting exposure of peripheral nerves to chemotherapy agents. The aim of this study is to evaluate whether continuous-flow cryotherapy at 15°C during weekly paclitaxel administration can reduce the incidence and severity of CIPN in breast cancer patients.
Participants receiving continuous-flow cryotherapy will be compared with participants receiving standard care without cryotherapy. During chemotherapy treatment and throughout the first year of follow-up, all participants will undergo serial assessments of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and laboratory testing. In addition to routine blood tests, extra blood samples will be collected at two time points to assess biomarkers associated with nerve damage.
- Conditions
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN, CIPN in Adjuvant Breast Cancer Patients, Chemotherapy Induced Peripheral Neuropathy, Chemotherapy Induced Peripheral Neuropathy (CIPN)
- Being tested
- Cryotherapy
- Keywords
- CIPN, Cryotherapy, TNSn score, multimodal assessment, breast cancer, paclitaxel weekly
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
Hilotherm Chemocare™ is a dedicated cryotherapy device designed for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy. The system consists of a closed-loop circulation unit through which a temperature-controlled cooling medium is delivered to specially designed cuffs applied to the hands and feet. A processor-controlled system maintains a stable and continuous temperature throughout the treatment session.
For CIPN prevention, the manufacturer-recommended target temperature is set at 15°C. Cryotherapy will be administered starting 15 minutes before the initiation of chemotherapy infusion, continued throughout the entire duration of chemotherapy administration, and maintained for 15 minutes after completion of the infusion.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | Patients will receive standard of care |
| Cryotherapy arm | Experimental | Cold will be administered to the hands and feet using continuous-flow cryotherapy at 15°C, starting 15 minutes before, continuing during, and ending 15 minutes after each weekly paclitaxel infusion. Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Total Neuropathy Score-Nurse Version (TNSn)
The Total Neuropathy Score-Nurse Version (TNSn) is a clinician-administered composite measure of chemotherapy-induced peripheral neuropathy. It comprises 5 items (sensory symptoms, motor symptoms, autonomic symptoms, pin-prick sensibility and vibration sensibility), each scored from 0 to 4 and summed to yield a total score ranging from 0 (minimum, no neuropathy) to 20 (maximum, most severe neuropathy); higher scores indicate a worse outcome. For each participant, the change from baseline is calculated as the TNSn total score at 6 months after completion of chemotherapy minus the TNSn total score at baseline. Positive values indicate worsening of neuropathy. The outcome is summarized per arm as the mean change with standard deviation.
Measured: Baseline (before the first paclitaxel infusion) and 6 months after completion of paclitaxel treatment (approximately 9 months from baseline)
Secondary outcomes (3)
Mean Change From Baseline in Peak-to-Peak Amplitude of the Dorsal Sural Sensory Nerve Action Potential (µV)
Peak-to-peak amplitude of the dorsal sural sensory nerve action potential (SNAP), measured in microvolts (µV) by sensory nerve conduction study on the non-dominant lower limb with surface electrodes (2-channel EMG). For each participant, the change from baseline is calculated at each post-baseline time point as the amplitude at that time point minus the baseline amplitude. Negative values indicate a decrease in amplitude compared with baseline; lower amplitudes indicate greater sensory nerve dysfunction (axonal loss). The outcome is summarized per arm as the mean change with standard deviation.
.
Measured: Baseline (before the first paclitaxel infusion), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline)
Mean Change From Baseline in Serum Neurofilament Light Chain (NfL) Concentration (pg/mL)
Serum neurofilament light chain (NfL) concentration, measured in pg/mL by single-molecule array (Simoa) immunoassay as a biomarker of neuroaxonal damage. For each participant, the change from baseline is calculated as the post-baseline value minus the baseline value. Higher concentrations indicate greater neuroaxonal injury. The outcome is summarized per arm as the mean change with standard deviation.
Measured: Baseline (before the first paclitaxel infusion), mid-chemotherapy (cycle 6, approximately 6 weeks)
Mean Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Subscale Score
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale is a validated patient-reported questionnaire assessing chemotherapy-induced neurotoxicity. It comprises 11 items, each rated from 0 to 4 and scored according to the FACIT manual to yield a subscale score ranging from 0 (minimum) to 44 (maximum); lower scores indicate more severe neurotoxicity (worse outcome) and higher scores indicate fewer symptoms (better outcome). For each participant, the change from baseline is calculated at each post-baseline time point as the subscale score at that time point minus the score at baseline. Negative values indicate worsening of patient-reported neurotoxicity. The outcome is summarized per arm as the mean change with standard deviation.
Measured: Baseline, cycles 3, 6, 8, 10 and 12 (approximately 3, 6, 8, 10 and 12 weeks), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start11 Oct 2025
- Primary completionJul 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria dell'Alto Adige
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca, Paracelsus Medical University
- Responsible party
- Sponsor
- Investigators
- Sonia Prader, MD, Study chair, Azienda Sanitaria dell'Alto Adige
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780955
- Sponsor's protocol ID
- 100-2023
- Status last verified
- Aug 2026
- First submitted
- 18 May 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Evaluation of Cryotherapy to Reduce Incidence of Chemotherapy-induced Peripheral Neurotoxicity in Breast Cancer Patients Treated With Paclitaxel Weekly
- ClinicalTrials.gov ID
- NCT07780955
- Acronym / sponsor ID
- 100-2023
- Conditions
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN, CIPN in Adjuvant Breast Cancer Patients, Chemotherapy Induced Peripheral Neuropathy, Chemotherapy Induced Peripheral Neuropathy (CIPN)
- Keywords
- CIPN, Cryotherapy, TNSn score, multimodal assessment, breast cancer, paclitaxel weekly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Azienda Sanitaria dell'Alto AdigeUniversity, hospital or other
- Collaborators
- University of Milano Bicocca, Paracelsus Medical University
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 24 Aug 2026 (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.
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), which may negatively affect quality of life and lead to treatment modifications or discontinuation. The aim of this clinical trial is to evaluate whether acral cryotherapy during chemotherapy administration can reduce the incidence and severity of CIPN.
Participants receiving cryotherapy will be compared with participants receiving standard care without cryotherapy. During chemotherapy treatment and throughout the first year of follow-up, all participants will undergo serial evaluations of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and blood tests. In addition to routine laboratory testing, extra blood samples will be collected at two time points to assess biomarkers of nerve damage.
Detailed description
Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), a frequent and potentially dose-limiting toxicity caused by damage to peripheral nerves. Symptoms of CIPN may persist long after treatment completion and can significantly impair quality of life and daily functioning.
The application of cold to the hands and feet during chemotherapy administration may reduce the incidence and severity of CIPN by decreasing local blood flow and limiting exposure of peripheral nerves to chemotherapy agents. The aim of this study is to evaluate whether continuous-flow cryotherapy at 15°C during weekly paclitaxel administration can reduce the incidence and severity of CIPN in breast cancer patients.
Participants receiving continuous-flow cryotherapy will be compared with participants receiving standard care without cryotherapy. During chemotherapy treatment and throughout the first year of follow-up, all participants will undergo serial assessments of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and laboratory testing. In addition to routine blood tests, extra blood samples will be collected at two time points to assess biomarkers associated with nerve damage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –Patients will receive standard of care |
| Cryotherapy arm | Experimental | Device: CryotherapyCold will be administered to the hands and feet using continuous-flow cryotherapy at 15°C, starting 15 minutes before, continuing during, and ending 15 minutes after each weekly paclitaxel infusion. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Paclitaxel weekly (80 mg/m2) at least 12 cycles (in adjuvant, neo-adjuvant setting or metastatic setting following the present schemes: TH (Paclitaxel, Trastuzumab), AC-TH (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab), AC-THP (Doxorubicin, Cyclophosphamide, Paclitaxel, Trastuzumab, Pertuzumab), AC-T (Doxorubicin, Cyclophosphamide, Paclitaxel)
- Eastern Cooperative Oncology Group Performance Status (ECOG) < 2
- Female sex
- Age: 18-90 years
- written informed consent
Key exclusion criteria (8 listed)
- pre-existing motor/sensitive peripheral neuropathy
- diabetes
- Endocrinopathies
- presence of brain, bone, soft tissue, or skin of hands or feet metastases
- Raynaud's syndrome
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 |
|---|---|---|
| CryotherapyHilotherm Chemocare™ is a dedicated cryotherapy device designed for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving neurotoxic chemotherapy. The system consists of a closed-loop circulation unit through which a temperature-controlled cooling medium is delivered to specially designed cuffs applied to the hands and feet. A processor-controlled system maintains a stable and continuous temperature throughout the treatment session. For CIPN prevention, the manufacturer-recommended target temperature is set at 15°C. Cryotherapy will be administered starting 15 minutes before the initiation of chemotherapy infusion, continued throughout the entire duration of chemotherapy administration, and maintained for 15 minutes after completion of the infusion. | Device | Cryotherapy arm |
Primary outcome
Mean Change From Baseline in Total Neuropathy Score-Nurse Version (TNSn)
Time frame: Baseline (before the first paclitaxel infusion) and 6 months after completion of paclitaxel treatment (approximately 9 months from baseline)
The Total Neuropathy Score-Nurse Version (TNSn) is a clinician-administered composite measure of chemotherapy-induced peripheral neuropathy. It comprises 5 items (sensory symptoms, motor symptoms, autonomic symptoms, pin-prick sensibility and vibration sensibility), each scored from 0 to 4 and summed to yield a total score ranging from 0 (minimum, no neuropathy) to 20 (maximum, most severe neuropathy); higher scores indicate a worse outcome. For each participant, the change from baseline is calculated as the TNSn total score at 6 months after completion of chemotherapy minus the TNSn total score at baseline. Positive values indicate worsening of neuropathy. The outcome is summarized per arm as the mean change with standard deviation.
3 secondary outcomes
Mean Change From Baseline in Peak-to-Peak Amplitude of the Dorsal Sural Sensory Nerve Action Potential (µV)
Time frame: Baseline (before the first paclitaxel infusion), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline)
Mean Change From Baseline in Serum Neurofilament Light Chain (NfL) Concentration (pg/mL)
Time frame: Baseline (before the first paclitaxel infusion), mid-chemotherapy (cycle 6, approximately 6 weeks)
Mean Change From Baseline in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Subscale Score
Time frame: Baseline, cycles 3, 6, 8, 10 and 12 (approximately 3, 6, 8, 10 and 12 weeks), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline)
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 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sonia Prader, MD study chair
Azienda Sanitaria dell'Alto Adige
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and CIPN, run by Azienda Sanitaria dell'Alto Adige at 4 sites 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Mattia Bergamo, MD (+390472812568, mattia.bergamo@sabes.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Total Neuropathy Score-Nurse Version (TNSn) (time frame: Baseline (before the first paclitaxel infusion) and 6 months after completion of paclitaxel treatment (approximately 9 months from baseline)). 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 24 Aug 2026.