Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT06541769
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06541769
Study Brief:
Protocol Section:
NCT06541769