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Completed

NCT Number: NCT02846844

Patients With Chemotherapy-induced Polyneuropathy Are Treated With an Integrated Program Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises or With Whole-body Vibration Platform Training

In a Phase-III Study Patients With Chemotherapy-induced Polyneuropathy (NCI CTC Grade 2/3) Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises (Standard) or With Whole-body Vibration (WBV) Platform Training (Experimental).

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Key information

Conditions

Polyneuropathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

Subjects with a haematological malignancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy. In a phase-III study patients with chemotherapy-induced polyneuropathy (NCI CTC grade 2/3) are randomized for an integrated program (IP) including massage, mobilization in posture and transport layers, physical exercises (standard) or with whole-body vibration (WBV) platform training (experimental). 15 training sessions in a time period of 12 to 15 weeks were intended. Evaluation included locomotor and neurological tests and self-assessment-tools. The primary objective of the study was the physical fitness and coordination assessed by the chair-rising test (CRT).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients 18 to 70 years of age with solid and hematological neoplasms suffering from chemotherapy-induced polyneuropathy grade II-III according to National Cancer Institute Common Toxicity Criteria (NCI CTC, version 3.0) and pathological chair-rising test (CRT)28 ( ≥10 s) were eligible

Exclusion criteria

  • psychiatric disorders
  • plasmatic coagulation disorders
  • thrombotic/thromboembolic events within 6 months before randomization
  • severe neurological disorders like seizures

Treatment and study plan

Primary outcomes

  1. • The primary endpoint of the study was achievement of normal values (<10 seconds) in the chair-rising test at the last assessment 4 weeks after the last intervention.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

Study Patients With Chemotherapy-induced Polyneuropathy Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises or With Whole-body Vibration Platform Training

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2016
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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