Status:
COMPLETED
CIPN-prevention Trial Evaluating the Efficacy of Hand-cooling and Hand-compression
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Onychodystrophy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 n...
Detailed Description
This is a prospective, randomized, two-arm study with the aim of assessing the effectiveness of compression or cooling in preventing higher-grade CIPN (\>Grade 2 according to EORTC) during weekly pacl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2022
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06541769
Start Date
October 15 2019
End Date
July 15 2022
Last Update
August 7 2024
Active Locations (1)
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1
National Center for Tumor diseases (NCT)
Heidelberg, Germany, 69120