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Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy

NCT07780955 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-08-24

No results posted yet for this study

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 - Chemotherapy-Induced Peripheral Neuropathy
  • CIPN
  • CIPN in Adjuvant Breast Cancer Patients
  • Chemotherapy Induced Peripheral Neuropathy
  • Chemotherapy Induced Peripheral Neuropathy (CIPN)

Interventions

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.

Sponsors & Collaborators

  • University of Milano Bicocca

    collaborator OTHER

  • Paracelsus Medical University

    collaborator OTHER

  • Azienda Sanitaria dell'Alto Adige

    lead OTHER

Principal Investigators

  • Sonia Prader, MD · Azienda Sanitaria dell'Alto Adige

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-11
Primary Completion
2028-07-31
Completion
2028-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07780955 on ClinicalTrials.gov