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STOP Studie - PNP Prävention

AcronymISRCTNEudraCTClinicaltrials.govDRKS
DRKS00006088

The influence of sensorimotor training and vibration training on the development of chemotherapy-induced peripheral polyneuropathy.

Status: Active

Purpose / Objectives

Primary Outcome

  • To prevent the occurrence of neurological secured neuropathy (≥ grade 1)

Secondary Outcomes

  • Prevention of neuropathic symptoms
  • Prevention of neuropathic pain              
  • Maintaining quality of life
  • Enable to obtain the planned medical treatment

Diagnosis

Peripheral Neuropathy (PNP)

Patient attributes

Age

18-99

Inclusion criteria

  • > 18years
  • Presence of a cancer is treated with either vinca alkaloid or oxaliplatin-based chemotherapy

Exclusion criteria

  • Presence of PNP from other causes (diabetes, HIV, alcohol abuse)
  • All disease situations that do not allow a sports activity
  • Upcoming, planned surgery
  • CNS metastases

Trial design

  • Phase IV
  • Multicenter
  • Prospective
  • Randomized
  • Three-arm
  • Open Label

Intervention

The subjects receive an accompanying chemotherapie individual training.This training is adapted to the needs of oncology subjects. Each training session lasts approximately 15-30 min. Depending on the randomization, subjects receive either the sensorimotor training, vibration training or control training.

Miscellaneous

sensorimotor training (see protocol)

vibration training (see protocol)

control training (see protocol)

Documents (password protected)

Responsibilities in overall trial

Medizinische Fakultät der Universität zu Köln

National Coordinating Investigator

Prof. Dr. Wilhelm Bloch

Study Sites

Klinik I für Innere Medizin

Study office

  • AG Onkologische Bewegungsmedizin

    Status

    Active

    Principal Investigator

    PD Dr. med. Thomas Elter

    Contact at Site