An interventional study of Cryotherapy in CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN and CIPN in Adjuvant Breast Cancer Patients, sponsored by Azienda Sanitaria dell'Alto Adige. Recruiting at 4 sites in Italy. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Azienda Sanitaria dell'Alto Adige · Not applicable, Interventional, and Prevention
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 144 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Azienda Sanitaria dell'Alto Adige is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive standard of care
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.
Device: Cryotherapy
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.
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.
Time frame: Baseline (before the first paclitaxel infusion) and 6 months after completion of paclitaxel treatment (approximately 9 months from baseline)
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. .
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)
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.
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
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.
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)
Mean Change From Baseline in Peak-to-Peak Amplitude of Sensory Nerve Action Potentials (microvolts)
Peak-to-peak amplitude of sensory nerve action potentials (SNAP), measured in microvolts (uV) by sensory nerve conduction study on the non-dominant side with surface electrodes (2-channel EMG). For each participant and each nerve, 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. Results will be reported separately for each nerve assessed (sural nerve, ulnar nerve). The outcome is summarized per arm as the mean change with standard deviation.
Time frame: Baseline, cycle 6 (approximately 6 weeks), cycle 12 / end of chemotherapy (approximately 12 weeks), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline)
Mean Change From Baseline in Peak-to-Peak Amplitude of Compound Muscle Action Potentials (millivolts)
Peak-to-peak amplitude of compound muscle action potentials (CMAP), measured in millivolts (mV) by motor nerve conduction study on the non-dominant side with surface electrodes (2-channel EMG). For each participant and each nerve, 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 motor nerve dysfunction. Results will be reported separately for each nerve assessed (peroneal nerve, ulnar nerve). The outcome is summarized per arm as the mean change with standard deviation.
Time frame: Baseline, cycle 6 (approximately 6 weeks), cycle 12 / end of chemotherapy (approximately 12 weeks), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline)
Mean Change From Baseline in Sensory Nerve Conduction Velocity (m/s)
Sensory nerve conduction velocity, measured in metres per second (m/s) by sensory nerve conduction study on the non-dominant side with surface electrodes (2-channel EMG). For each participant and each nerve, the change from baseline is calculated at each post-baseline time point as the conduction velocity at that time point minus the baseline velocity. Negative values indicate slowing of conduction compared with baseline; lower velocities indicate greater sensory nerve dysfunction. Results will be reported separately for each nerve assessed (dorsal sural nerve, sural nerve, ulnar nerve). The outcome is summarized per arm as the mean change with standard deviation.
Time frame: Baseline, cycle 6 (approximately 6 weeks), cycle 12 / end of chemotherapy (approximately 12 weeks), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline)
Mean Change From Baseline in Motor Nerve Conduction Velocity (m/s)
Motor nerve conduction velocity, measured in metres per second (m/s) by motor nerve conduction study on the non-dominant side with surface electrodes (2-channel EMG). For each participant and each nerve, the change from baseline is calculated at each post-baseline time point as the conduction velocity at that time point minus the baseline velocity. Negative values indicate slowing of conduction compared with baseline; lower velocities indicate greater motor nerve dysfunction. Results will be reported separately for each nerve assessed (peroneal nerve, ulnar nerve). The outcome is summarized per arm as the mean change with standard deviation.
Time frame: Baseline, cycle 6 (approximately 6 weeks), cycle 12 / end of chemotherapy (approximately 12 weeks), and 3, 6 and 12 months after completion of paclitaxel treatment (up to approximately 15 months from baseline)
Mean Change From Baseline in Total Neuropathy Score-Nurse Version (TNSn) at All Scheduled Assessments
The Total Neuropathy Score-Nurse Version (TNSn) is a clinician-administered composite measure of chemotherapy-induced peripheral neuropathy comprising 5 items, 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 at each post-baseline time point as the TNSn total score at that time point minus the baseline score. Positive values indicate worsening of neuropathy. The outcome is summarized per arm as the mean change with standard deviation.
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)
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