Trial document




drksid header

  DRKS00011518

Trial Description

start of 1:1-Block title

Title

Exercise therapy for the prevention of chemotherapy-induced peripheral neuropathy

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

InterBALANCE

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.medizin.uni-halle.de/index.php?id=7352&L=1%20%27

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Peripheral neuropathy is a serious and treatment limiting side effect of certain kinds of chemotherapy . Patients suffer from tingling or numbness, muscle weakness or pain in hand and feet. Studies showed that training of balance and coordination can reduce the restriction of the nerval damage.
Interbalance examines if a prophylactic training of coordination and balance accompanying the chemotherapy can prevent the nerval damage. For this purpose, tumor patients who begin with a chemotherapeutic treatment receive additionally a classical balance training, a computer-assisted training or the standard supply. The balance training takes place twice a week for a total of 12 weeks. Before and after the 12 weeks as well as after a further 4 weeks, various measurements for nerve impairment and neuropathy are carried out for all tumor patients and then the results of the patients with and without training are compared with each other.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The chemotherapy-induced peripheral neuropathy (CIPN) is a common side-effect of several cheotherapeutic treatments. Standardized prophylactic measures or causal medical therapy approaches are not available for the CIPN. In the field of non-drug therapy, exercice like balance training has proved to be a potential treatment option for reducing the symptoms of CIPN. How far the prophylactic exercise can prevent the occurrence of CIPN is currently unclear.
In this three-arm, randomized-controlled study it is investigated whether the or the severity of CIPN can be reduced by a 12-week prophylactic exercise programm compared to no prophylaxis in tumor patients at high risk for a CIPN. One intervention arm includes a classic balance training, another a computer-assisted balance training with the Nintendo Wii balanceboard. The third arm receives the standard supply without additional exercise. The primary endpoint is the CIPN-specific quality of life (QLQ-CIPN 20) as patient reported outcome. Neurological parameters and coordinative functions are considered as secondary endpoints. The data is collected before the beginning of the intervention (baseline = T1), directly after the intervention (T2 = after 12 weeks) and a follow-up (T3 = 4 weeks after the end of the intervention).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011518
  •   2017/01/20
  •   [---]*
  •   yes
  •   Approved
  •   2016-89, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C00-C97 -  Malignant neoplasms
  •   G62.0 -  Drug-induced polyneuropathy
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Balance training two times/week (20-30 minutes) over 12 weeks at neurotoxic chemotherapy onset
  •   Balance training with force platform and visual feedback two times/week (20-30 minutes) over 12 weeks at neurotoxic chemotherapy onset
  •   Standard therapy without supplementary exercise
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

change of patient-reported quality of life (questionnaire: EORTC-QLQ-CIPN20) between baseline (week 0, t1), end of intervention (week 12, t2) and follow-up (week 16, t3)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

change of quality of life (EORTC-QLQ-C30), neuropathy related pain (Pain-Detect), pallesthesia (tuning fork), sensory disburtance (numbness, tingling, temperature), electrical impulses of muscles (electromyographie, MUAP), nerve conduction velocity and sympathetic skin response (electroneurography), mobility (TUGT), postural control (posturographic, IBS Tetrax),
muscular proprioceptive reflex (patellar/achilles) and neuropathy scores (CTC AE 4.3, Total Neuropathy Score) between baseline (week 0, t1), end of intervention (week 12, t2) and follow-up (week 16, t3)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/01/26
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   15   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

histologically confirmed tumor diagnosis (main diagnosis), therapy with platinum derivatives, taxanes or vincristine, living in Halle or in the immediate surroundings, adequate mobility and autonomy, written consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

no suitability for participation in the study from the medical point of view, Relevant disturbance of pallesthesia (tuning fork) / pre-existing polyneuropathy, lack of german language skills

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik und Poliklinik für Innere Medizin IV
    • Ms.  Dr. med.  Franziska  Jahn 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin IV
    • Ms.  Dr. med.  Franziska  Jahn 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Halle (Saale) Landeszentrum für Zell- und Gentherapie Onkologische Sport- und Bewegungstherapie
    • Mr.  André  Golla 
    • Ernst-Grube-Straße 40
    • 06120  Halle (Saale)
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Wilhelm-Roux-Förderprogramm der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg, Prodekanat Forschung
    • Magdeburger Str. 8
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2018/05/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.