NCT07780955 Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy
| NCT ID | NCT07780955 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Sanitaria dell'Alto Adige |
| Condition | CIPN - Chemotherapy-Induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-10-11 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2025-10-11 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Sonia Prader, MD
STUDY CHAIR
Azienda Sanitaria dell'Alto Adige
Frequently Asked Questions
Who can join the NCT07780955 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 90 Years, studying CIPN - Chemotherapy-Induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07780955 currently recruiting?
Yes, NCT07780955 is actively recruiting participants. Contact the research team at mattia.bergamo@sabes.it for enrollment information.
Where is the NCT07780955 trial being conducted?
This trial is being conducted at Bolzano, Italy, Brixen, Italy, Bruneck, Italy, Merano, Italy.
Who is sponsoring the NCT07780955 clinical trial?
NCT07780955 is sponsored by Azienda Sanitaria dell'Alto Adige. The principal investigator is Sonia Prader, MD at Azienda Sanitaria dell'Alto Adige. The trial plans to enroll 144 participants.