Clinical trial · Interventional
Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy
Multimodal Evaluation of Cryotherapy to Reduce Incidence of Chemotherapy-induced Peripheral Neurotoxicity in Breast Cancer Patients Treated With Paclitaxel Weekly
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Chemotherapy Induced Peripheral Neuropathy (CIPN) | — | UNRESOLVED | — |
| CIPN | — | UNRESOLVED | — |
| CIPN - Chemotherapy-Induced Peripheral Neuropathy | — | UNRESOLVED | — |
| CIPN in Adjuvant Breast Cancer Patients | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Patients will receive standard of care
- type
- EXPERIMENTAL
- label
- Cryotherapy arm
- description
- 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.
- interventionNames
- Device: Cryotherapy
Primary outcomes (1)
- measure
- Mean Change From Baseline in Total Neuropathy Score-Nurse Version (TNSn)
- timeFrame
- Baseline (before the first paclitaxel infusion) and 6 months after completion of paclitaxel treatment (approximately 9 months from baseline)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available