C00-C75 C50-C50 C15-C26 C81-C96
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: >18years old indication for chemotherapy containing either Oxaliplatin or vinka alcaloid
Exclusion criteria
Exclusion criteria: - PNP (NCV <40; amp <5) of other derivation (such as diabetes, HIV, alcohol) - all conditions preventing the active particpation in physical activity - contraindications for vibration exercises (osteolyses, osteosyntheses, hip-TEP, a fracture of the lower extremities in the past 2 years, acute thrombosis, foot ulcers, fresh wounds and scar tissue) - planed operation - unwillingness to sign the informed consent and data protection - uncontrolled cerebral seizures - CNS metastases - physical or psychological condition that does not allow the participation in a study or a legal signature for the informed consent statement, according to the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Onset and time-point of chemotherapy-induced peripheral neuropathy (Nerve conduction velocity (<40) and amplitude (<5) via neuroeletrography, Achilles- and patellar reflexes with a reflex hammer, peripheral deep sensitivity with a tuning fork, proprioception- manually) Baseline assessment will be performed prior to therapy (T0), once neuropathy related symptoms are reported (T1) (which will also be checked every 6 weeks via a short neurological assessment -solely excluding the neuroelectrography) and after completion of therapy - after 2-3months (T2). In case therapy continues for more than 3 months, T2 will be performed as an intermediate measuring point and a further will be necessary after completion of therapy (T3). | — |
Secondary
| Measure | Time frame |
|---|---|
| subjective assessment of neuropathy related symptoms (FACT-gog-ntx) Quality of life (EORTC-QLQ-C-30) Neuropathy related pain (PAIN-DETECT) level of activity (GPAQ) Baseline assessment will be performed prior to therapy (T0), once neuropathy related symptoms are reported or identified (T1) and after completion of therapy - after 2-3months (T2). In case therapy continues for more than 3 months, T2 will be performed as an intermediate measuring point and a further will be necessary after completion of therapy (T3). | — |
Countries
Germany
Contacts
Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt. II