Trial document




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  DRKS00005419

Trial Description

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Title

Impact of physical exercise on neuropathic symptoms in cancer patients

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Trial Acronym

PNP-study

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URL of the Trial

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Brief Summary in Lay Language

Polyneuropathies [PNP] can be caused by neurotoxic chemotherapeutic drugs, which cause damage in the nervous system. Affecting peripheral sensory and motor nerve pathways neuropathies are noticeable in paresthesia of hands and feet and in motor dysfunctions. As there is no prescribed medication prophylaxis or therapy to reduce the neuropathic symptoms, the primary goal of the PNP-study is to find out whether a specific training program influences the described symptoms.
The target group of the study are cancer patients with symptoms of PNP and terminated cancer therapy, which are allocated either in the intervention or active control group. Both groups receive a training program over 12 weeks, two times per week. The intervention group performs a cardiovascular warm up as well as a balance training, whereas the patients of the control group participate in an endurance bicycle ergometer training.

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Brief Summary in Scientific Language

The study will follow a prospective randomized controlled design allocating the patients in two groups: an intervention group [IG] and an active control group [CG]. Both groups receive an exercise program twice per week over 12 weeks: on balance training focused exercises for IG and moderate endurance training for CG. Intervention period is followed by a follow-up period of also 12 weeks. There will be three assessments points in total: at baseline (T0), after intervention (T1) and after of follow-up (T2).
The design is based on experiences of the lymphoma study and the pilot study, as well as previous studies (Allet et al., 2010; Fisher et al., 2007) and a current study of Sartor et al. (2012).

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Organizational Data

  •   DRKS00005419
  •   2013/11/19
  •   [---]*
  •   yes
  •   Approved
  •   399/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Patienten mit Polyneuropathie
  •   C00-C97 -  Malignant neoplasms
  •   G60-G64 -  Polyneuropathies and other disorders of the peripheral nervous system
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Interventions/Observational Groups

  •   The intervention group receives a specific exercise program (1 hour) twice a week over a period of 12 weeks. The training is supervised by a sports therapist and contains a cardio-vascular warm-up (without postural effects) and a balance training (with postural effects).
  •   The control group receives moderate aerobic endurance training. The training duration will firstly start with 10min and then increase up to 30min in 5min steps. Training sessions take place twice a week over 12 weeks like the training protocol of IG.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Supportive care
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Change (%) of sway path (cm) of CoF (=centre of force) [force plate]
To be measured at all three measurement-times: T0 (baseline), T1 (after 12 weeks intervention), and T2 (after 12 weeks follow-up).

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Secondary Outcome

The following secondary endpoints are messured at all three messurement-points (T0 (baseline), T1 (after 12 weeks intervention), and T2 (after 12 weeks follow-up)):
- Body sway path (cm) and velocity (mm/s) [opto-electric system and a force plate]
- Chair-rising test (sec) [force plate]
- Nerve conduction velocity (m/s) and amplitude (mm) of stimulus response [neurography]
- Patellar and Achilles tendon reflex [reflex hammer] and deep sensibility [tuning fork (scale)]
- Subjective PNP-symptoms [FACT/GOG-Ntx- questionnaire]
- Quality of life [EORCT-QLQ-C30-questionnaire]
- Performance (watt) at the individual anaerobic threshold [(lactate diagnostic and spiroergometry) by standard incremental bicycle exercise test including ECG3 (electrocardiogram)]
- Maximum strength [counter movement jump on force plate]
- Physical activity per week (MET = metabolic equivalent) [FFKA-questionnaire]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2013/12/13
  •   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

- Patients with haematological/oncological malignancies and symptoms of PNP regardless
their malignant underlying disease
- Completed chemotherapy
- Age ≥18 years
- Performance- Status Karnofsky- Index >60
- Signed informed consent
- Geographical proximity (<90 Minutes with transport)

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Exclusion Criteria

Absolute:
- Instable bone metastases
- Myocardial infarction, Angina pectoris or heart disease (NYHA III-IV) in a time period of six
months
- Arterial hypertension, which is not treated adequately (in therapy >180mmHg systolic;
>100mmHg diastolic)
- Patients with an increased risk for thrombosis besides underlying disease
- Pregnancy
Relative (inclusion or continuation after recovery possible):
- Acute infection (≥38,0°Celcius and/ or intravenously therapy with antibiotics)
- Thrombocytes < 10x109/l
- Leukocytes < 1x109/l

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Addresses

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    • Universitätsklinik Freiburg, Klinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Prof. Dr.   Hartmut  Bertz 
    • Hustetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universität Freiburg Institut für Sport und Sportwissenschaft
    • Mr.  Professor  Albert  Gollhofer 
    • Schwarzwaldstr. 175
    • 79117  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Neurozentrum
    • Mr.  PD Dr.  Christioph  Maurer 
    • Breisacherstr. 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Department Innere Medizin Institut für Bewegungs- und Arbeitsmedizin
    • Mr.  Prof. Dr.  Peter  Deibert 
    • Hugstetterstr. 55
    • 79106  Freiburg. i. Br.
    • Germany
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    • Universitätsklinik Freiburg, Klinik für Innere Medizin I, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Prof. Dr.  Hartmut  Bertz 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Janssen-Cilag GmbH
    • Johnson & Johnson Platz 1
    • 41470  Neuss
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/26
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Trial Publications, Results and other Documents

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