The preventive effect of Sensorimotor- and vibration exercises on the onset of Oxaliplatin- or vinka alcaloid induced peripheral neuropathies

Not Applicable

Recruiting

• Conditions: C00-C75; C50-C50; C15-C26; C81-C96; Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue; Malignant neoplasm of breast; Malignant neoplasms of digestive organs; Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue

• Registration Number: DRKS00006088
• Lead Sponsor: Insitut für Kreislaufforschung und Sportmedizin der Deutschen Sporthochschule Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

>18years old
indication for chemotherapy containing either Oxaliplatin or vinka alcaloid

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) <br>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). <br>

Secondary Outcome Measures

Name	Time	Method
subjective assessment of neuropathy related symptoms (FACT-gog-ntx)<br>Quality of life (EORTC-QLQ-C-30) <br>Neuropathy related pain (PAIN-DETECT)<br>level of activity (GPAQ)<br>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).