G62.0
Conditions
Interventions
Group 1: Tumor patients with planned neurotoxic chemotherapy:
1) serial measurements of Neurofilament light chain in serum
2) serial assessment of Total Neuropathy Score
3) serial assessment of qualit
Sponsors
Charité Universitätsmedizin BerlinKlinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - written informed consent is present - the patient is capable of giving consent (he/she is capable of understanding the nature, possible benefits and possible risks of a participation in the study) - minimum age 18 years - The participant belongs to one of the following groups: (a) planned neurotoxic chemotherapy (e.g. (nab-)paclitaxel, cisplatin, oxaliplatin, carboplatin, vincristine, bortezomib or a combination of these) b) Diagnosis of gynecologic malignancy and planned nerve-sparing surgery c) Diagnosis of uterus myoma and/or endometriosis and planned laparascopy/laparotomy
Exclusion criteria
Exclusion criteria: - the participant is not capable of giving consent - the participant is legally detained in an official institution - the participant has a pre-existing polyneuropathy with a TNSc of >5 points at V0 or V1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serial neurofilament light chain protein (NFL) determinations in serum at V0 (preoperative), V1 (before chemotherapy), V2 (after 50% of intended chemotherapy cycles), V3 (after completion of chemotherapy respectively at the second staging in patients with palliative chemotherapy), and optionally V4 (1 year after V3). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Cumulative chemotherapy dose (mg/m2) 2) Assessment of subjective CIPN severity and progression by EORTC-CIPN20 questionnaire. 3) Assessment of objective CIPN severity and progression by TNSc. 4) Assessment of quality of life by EORTC-QLQ-C30 questionnaire 5) Pre- and postoperative NFL measurements in case of nerve-sparing surgery 6) Recording of fecal and urinary incontinence by means of standardized questionnaire and correlation to NFL measurements 7) Detection of olfactory disorders by means of 5 defined odorants and correlation to NFL measurements 8) Influence of extremity cooling on CIPN development and severity and NFL measurements | — |
Countries
Germany
Contacts
Public ContactPetra Hühnchen
Charité Universitätsmedizin BerlinKlinik für Neurologie
Outcome results
None listed