Trial document




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  DRKS00006181

Trial Description

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Title

Treatment of patients with breast cancer or gastrointestinal cancer and chemotherapy-induced polyneuropathia with whole body vibration (Galileo technology)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The chemotherapy-induced polyneuropathy (CiPNP) is an important dose-limiting factor within the use of neurotoxic chemotherapeutic agents. Due to the increasing use of neurotoxic substances in cancer therapy, the frequency of patients suffering from CiPNP is further growing. Pathogenetically the CiPNP results from damages of the axons of peripheral nerves or more rarely of the spinal ganglions. Patients complain about unpleasant paraesthesia particularly of foot and hands, which leads to clumsiness and insecurities if patients walk, stand or grab something. In some cases, the CiPNP is associated with (i) an increased sensitiveness to cold or (ii) an inclination to muscle cramps. Sporadically, patients suffer from troubles of the motor activity up to paraparesis. Correspondingly, the development of the CiPNP can lead to a clear impairment of physical performance and to a significant decrease in quality of life. In several (pre-)clinical studies, it is postulated, that the CiPNP can be improved by induction of a long lasting regeneration of sensomotoric nerve fibres. However, up to date there are neither effective therapies nor prophylactic interventions which are able to show enduring positive therapeutic effects on CiPNP. In the last years together with numerous partners from science and industry, we could further develop a whole-body vibration training. In several studies we were able to demonstrate, especially for astronauts, sportsmen, older people as well as for children with sensomotoric problems that this kind of vibration training can improve the regeneration of muscle, of the nerve system and of the skeleton system very effectively. Interestingly, first clinical investigations indicate that notably patients with CiPNP can profit considerably, even by a relative short-term training within a few weeks. In this first clinical trial we would like to verify this retrospective observations. For this, 50 patients with breast cancer or gastrointestinal cancer with CiPNP will be randomized (1:1) and 25 patients will be treated with the muscle vibration training. We hope, that this kind of training can regenerate peripheral nerves and thus improve both, the PNP-associated clinical disorders as well as the quality of life.

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Organizational Data

  •   DRKS00006181
  •   2014/07/17
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  •   yes
  •   Approved
  •   247/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Chemotherapy induced polyneuropathy
  •   G62 -  Other polyneuropathies
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Interventions/Observational Groups

  •   Interventional Group: The interventional group receives whole body vibration training with Galileo for three weeks besides to the individual rehabilitation program. The vibration training with Galileo occurs via 10 minutes on 5 days weekly over a period of 3 weeks with a frequency of 22 Hz. Before and after every training unit pulse, blood pressure, body temperature and physical disorders are documented. Correspondingly, we estimated 15 minutes for the duration of the daily training program (10 minutes of training + vital sign control + breaks).
  •   Control Group: The control group receives a three-weekly, individually adapted and to a large extent standardized rehabilitation program.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

(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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/07/17
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Tumorbiologie
    • Mr.  Prof. Dr. med.  Hans-Helge  Bartsch 
    • Breisacherstraße 117
    • 79106  Freiburg
    • Germany
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    • Klinik für Tumorbiologie
    • Mr.  Prof. Dr. med.  Hans-Helge  Bartsch 
    • Breisacherstraße 117
    • 79106  Freiburg
    • Germany
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    • Klinik für Tumorbiologie
    • Ms.  Dr. med.  Britta  Rudolphi 
    • Breisacherstraße 117
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Leonardis-Stiftung
    • Ms.  Charlotte   Rennebeck 
    • Am Gähkopf 10
    • 70192  Stuttgart
    • Germany
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    • Klinik für Tumorbiologie
    • Mr.  Prof. Dr. med.  Hans-Helge  Bartsch 
    • Breisacherstraße 117
    • 79106   Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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