Chemotherapy induced polyneuropathy G62
Conditions
Interventions
Group 1: Interventional Group: The interventional group receives whole body vibration training with Galileo for three weeks besides to the individual rehabilitation program. The vibration training wit
Sponsors
Klinik für Tumorbiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria • patients with breast cancer or gastrointestinal cancer and Chemotherapy-induced Polyneuropathy • rehabilitation planed for at least 3 weeks • no further chemotherapy is planed • age = 18 years • perfomance status: Karnofsky-Index = 80% • average of life expectancy of at least 4 months • patient is able (i) to understand the being, importance and range of the study and (ii) to give the approval for the participation in the study • signed informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria • diseases which are able to endangering the safety of the patients or which can influence the validity of the study • instable bone metastases or osteoporosis • myocardial infarction = 6 months, angina pectoris (when the angina pectoris is instable or starts = 3 months) • heart disease (NYHA = III) • uncontrolled hypertension • acute thrombosis • severe acute infection • acute discopathia, acute tendinopathia • acute inflammation of the hinges or of the movement apparatous • acute hernia • recurring Renal or Bilious colic • wounds fresh or being cured badly or ulcera or bone fractures • endoprosthesis or insufficient osteosynthetische supply • acute bleeding, gastrointestinale hemorrhage = 4 weeks • pregnancy • greater surgical intervention, difficult trauma = 4 weeks • heavy neuropathia (PNP Score = 7) • akute rheumatoid arthritis • epilepsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| polyneuropathic disorders Method: FACT/GOG-Ntx-Questionaire (%): Detection of subjective Symptoms Time of investigation: (T0) initial, (T1) after 3 weeks of treatment, (T2) 3 months after the start of the trail | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) postural control - body sway path [cm] of the centre of force [CoF]; (b) physical ablity for coordination - body sway path [cm] and velocity [mm/s, Hz]; (c) mobility and physical capacity - bounce [F, J], high jump [cm, J], Chair-Rising [sec, J]; (d) immune status and status of apoptosis - phenotypic and functional differentiation of white blood cells and detection of apoptosis parameters in serum (e) life quality - qualitiy of life score [%] Investigation with: (a) Mechanograph (Leonardo®, GRFP, Novotec Medical GmbH, Pforzheim); Time of investigation T0 and T1 (b) Posturography (Optotrack 3020™, Waterloo, Canada) and (Kistler™, Ostfildern, Germany); Time of investigation T0 and T1 (c) Mechanograph (Leonardo ® GRFP, Novotec Medical GmbH, Pforzheim): Time of investigation: T0 and T1 (d) FACS (Becton Dickinson, Heidelberg, Germany) and M30/65 ELISA (BIOAXXESS, Malvern, UK); Time of investigation: T0 and T1 (e) EORCT-QLQ-C30-questionnaire and EORTC-QLQ-CIPN20-questionaire (%): Time of investigation: T0, T1 and T2 | — |
Countries
Germany
Contacts
Public ContactBritta Rudolphi
Klinik für Tumorbiologie
Outcome results
None listed