Trial document




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  DRKS00006088

Trial Description

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Title

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

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Trial Acronym

STOP

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URL of the Trial

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Brief Summary in Lay Language

Patients receiving chemotherapy containing oxaliplatin or a vinc alcaloid, develop a chemotherapie-induced peripheral neuropathy (CIPN) to 70-90%. Previous studies have shown that specific exercise interventions have the potential to influence the onset and progression of peripheral neuropathies. We would therefore like to conduct a randomised, controlled, prospective study to evaluate the effects of sensorimotor- or vibration exercises on the onset of CIPN.

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Brief Summary in Scientific Language

The effects of sensorimotor- or vibration exercises on oxaliplatin- or vinc alkaloid-induced peripheral neuropathies.

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Organizational Data

  •   DRKS00006088
  •   2014/05/07
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  •   yes
  •   Approved
  •   21/2014, Ethikkommission der Deutschen Sporthochschule Köln, Institut für Pädagogik und Philosophie
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Secondary IDs

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Health Condition or Problem studied

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

  •   Sensorimotor training: the exercises are progressively difficult, starting bipedal on a static surface to monopedal on an instable surface. Four exercises will be performed per training session, each consisting of 3 repetitions with a duration of 20sec. and a rest of 40sec.. Between each exercise, a rest of 3min will be given in order to avoid neuronal fatigue. The Exercises will e perfomed barefoot or in socks, knees slightly bent (~30°) with the aim to maintain balance without holding on to sth or having to set the other foot down in the monopedal stance. The exercises will be performed at least twice a week for the entire duration of medical therapy (~2-3months).
  •   Patients will train on side-alternating vibration platform (Galileo Med M - Novotec). This training will also be conducted progressively. Patients will perfom 4 Exercises with a duration of 30sec.-2min at a frequency of 18-30Hz and an amplitude of 2-4mm. A rest of at least 1min, better 5min, must be kept between each exercise to avoid neuronal fatigue.
    The exercises will be performed at least twice a week for the entire duration of medical therapy (~2-3months).
  •   Patients in the control group will be given the standard medical care according to the current standards, once a neuropathy is diagnosed. This can involve medication such as Gabapentin or Pregabalin as well as physiotherapie but excluded sensorimotor- or vibration exercises.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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).

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Secondary Outcome

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).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/05/08
  •   158
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

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

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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

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Addresses

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    • Insitut für Kreislaufforschung und Sportmedizin der Deutschen Sporthochschule Köln
    • Mr.  Prof  Wilhelm  Bloch 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt. II
    • Ms.  Fiona  Streckmann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt. II
    • Ms.  Fiona  Streckmann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Kreislauffroschung und Sportmedizin der Deutschen Sporthochschule Köln
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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