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:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT03032718
Eligibility Criteria:
Inclusion Criteria:
* oncological patients with neurologically confirmed CIPN
* age: 18-80 years
* performance status of 0-2 according to the toxicity and response criteria of the Eastern Cooperative Oncology Group
* patients underwent neurotoxic chemotherapy with one of the following agents: Taxanes (docetaxel with a cumulative dose of ≥ 225mg/m2 or paclitaxel with a cumulative dose of ≥ 525mg/m2), Vinca-alkaloids (vincristine with a cumulative dose of ≥ 4.2mg/m2 or vinblastine with a cumulative dose of 24mg/m2), Platinum-derivatives (Oxaliplatin with a cumulative dose of ≥ 510mg/m2, Cisplatinum with a cumulative dose of ≥ 200mg/m2)
Exclusion Criteria:
* pre-existing neuropathy of other cause (e.g. diabetes)
* given contraindications for WBV (instable osteolysis, osteosynthesis, acute thrombosis, foot ulcers and a fracture of a lower extremity in the last two years)
* a myocardial infarction, angina pectoris or heart disease (NYHA III-IV) within the past six months
* a mental condition or lack of the German language that prevents the understanding of the written informed consent
* metastases of the central nervous system and epilepsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03032718
Study Brief:
Protocol Section:
NCT03032718