Clinical trial · Interventional
CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression
CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression in Patients Undergoing (Neo-) Adjuvant Chemotherapy for Primary Breast Cancer
- 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)
The POLAR study is a monocentric, prospective, randomized, 2-arm study designed to evaluate the effectiveness of compression or hypothermia in preventing higher-grade chemotherapy-induced peripheral neuropathy (CIPN) (Grade \> 1 according to EORTC) in patients undergoing (neo-)adjuvant chemotherapy with weekly Paclitaxel or Nab-Paclitaxel. In this study, the dominant hand of participants will be either cooled or compressed, while the contralateral hand will serve as a control. The treatment groups will be randomized. The primary aim of the study is to compare the effectiveness of limb hypothermia versus compression in preventing CIPN. Additionally, the investigators will assess the quality of life and therapy acceptance among the participants in both study arms. Data from the two groups will be collected and compared to determine the most effective intervention for preventing CIPN and to understand the overall impact on patients' well-being and treatment adherence.
Conditions
Conditions (2)
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 | — |
| Onychodystrophy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Limb compression | Device | — | UNRESOLVED |
| Limb hypothermia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypothermia
- description
- limb Hypothermia with special hypothermia-gel-gloves of the dominant hand starting 30min before chemotherapy application and ending 30min after. The glove will be changed every 30min to provide constant cooling
- interventionNames
- Device: Limb hypothermia
- type
- EXPERIMENTAL
- label
- Compression
- description
- compression of the dominant hand provided by one-way latex-gloves. The necessary size will be determined after measurement for every Patient individually
- interventionNames
- Device: Limb compression
Primary outcomes (1)
- measure
- Incidence of CIPN grade >1 on the interventional hand compared to the non-interventional hand
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- all female patients with signed informed consent who are starting with (neo-) adjuvant chemotherapy according to the following protocols: * 4 x Epirubicin/Cyclophosphamid (EC) q3w, followed by 12 x Paclitaxel weekly or 12x Nab-Paclitaxel (+/- Trastuzumab) * Paclitaxel or Nab-Paclitaxel weekly without anthracyclines * Paclitaxel or Nab-Paclitaxel weekly in combination with Carboplatin Exclusion criteria: * patients without informed consent * ECOG-Status \> 1 * age under 18 years * previous chemotherapy * therapy with SSNRI, SSRI, or tricyclic antidepressants especially duloxetine, gabapentine, pregabaline and amitryptiline. * known polyneuropathy (e.g. alcoholic PNP, nephrogenic PNP, diabetic PNP etc.) * Patients having diseases connected to PNP: * Sjögren-syndrome, sarkoidosis, amyloidneuropathy, Morbus Fabry, HSAN (Hereditary Sensoric and Autonome Neuropathy) * Guillain-Barré-syndrome, acute intermittent porphyria, critical-illness-PNP * Vaskulitides, HNPP, diabetic amyotrophy, multifokal motoric neuropathy, Lewis-Sumner-syndrome, borreliosis-neuropathy, Zoster-neuritis, neuralgic shoulder amyotrophy * Myelopathy, compression of the myelon, syringomyelia, meningomyelitis, Restless-Legs-syndrome * Sulcus-Ulnaris-syndrome, Loge-de-Guyon-syndrome, Medianus-compression-syndrome, multiple sklerosis, AML, Lupus erythematodes, sklerodermia/systemic sclerosis, Ehlers-Danlos-syndrome, CREST-syndrome, Raynaud-syndrome, cold aglutinin disease, hämatologic neoplasms, diabetes mellitus, chronic alcohol abuse, hepatitis C, known severe kidney disease
References
Publications (1)
- DERIVEDMichel LL, Schwarz D, Romar P, Feisst M, Hamberger D, Priester A, Kurre E, Klein E, Muller J, Schinkothe T, Weiler M, Smetanay K, Fremd C, Heublein S, Thewes V, Breckwoldt MO, Jager D, Bendszus M, Marme F, Schneeweiss A. Efficacy of Hand Cooling and Compression in Preventing Taxane-Induced Neuropathy: The POLAR Randomized Clinical Trial. JAMA Oncol. 2025 Apr 1;11(4):408-415. doi: 10.1001/jamaoncol.2025.0001. PMID 40048176