Serial Serum Neurofilament measurements for the diagnosis and prediction of chemotherapy-induced polyneuropathy

Recruiting

Conditions: G62.0
Drug-induced polyneuropathy

Registration Number: DRKS00027898

Lead Sponsor: Charité Universitätsmedizin BerlinKlinik für Neurologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 70

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

- 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1) Cumulative chemotherapy dose (mg/m2)<br>2) Assessment of subjective CIPN severity and progression by EORTC-CIPN20 questionnaire.<br>3) Assessment of objective CIPN severity and progression by TNSc.<br>4) Assessment of quality of life by EORTC-QLQ-C30 questionnaire<br>5) Pre- and postoperative NFL measurements in case of nerve-sparing surgery<br>6) Recording of fecal and urinary incontinence by means of standardized questionnaire and correlation to NFL measurements<br>7) Detection of olfactory disorders by means of 5 defined odorants and correlation to NFL measurements<br>8) Influence of extremity cooling on CIPN development and severity and NFL measurements