Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy

NCT07780955 | Recruiting

• 1 other identifier: 100-2023
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

CIPN; CIPN - Chemotherapy-Induced Peripheral Neuropathy; 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

  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)

Other Outcomes (5)

• Mean Change From Baseline in Peak-to-Peak Amplitude of Sensory Nerve Action Potentials (microvolts)

  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)

  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)

  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)

Study Arms (2)

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.

Device: Cryotherapy

Interventions

Cryotherapy DEVICE

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.

Cryotherapy arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paracelsus Medical University: collaborator
• Azienda Sanitaria dell'Alto Adige: lead
• University of Milano Bicocca: collaborator

Study Sites (4)

Ospedale di Bolzano

Bolzano, Bolzano, Italy

NOT YET RECRUITING

Ospedale di Bressanone

Brixen, Bolzano, 39042, Italy

RECRUITING

Ospedale di Brunico

Bruneck, Bolzano, 39031, Italy

RECRUITING

Ospedale di Merano

Merano, Bolzano, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sonia Prader, MD

  Azienda Sanitaria dell'Alto Adige

  STUDY CHAIR

Central Study Contacts

Mattia Bergamo, MD

CONTACT

+390472812568; mattia.bergamo@sabes.it

Study Design

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

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: August 24, 2026
• Study Start: October 11, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

IT (4)