Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyneuropathy
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a haematological malinancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy.

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: • 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.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schonsteiner SS, Bauder Missbach H, Benner A, Mack S, Hamel T, Orth M, Landwehrmeyer B, Sussmuth SD, Geitner C, Mayer-Steinacker R, Riester A, Prokein A, Erhardt E, Kunecki J, Eisenschink AM, Rawer R, Dohner H, Kirchner E, Schlenk RF. A randomized exploratory phase 2 study in patients with chemotherapy-related peripheral neuropathy evaluating whole-body vibration training as adjunct to an integrated program including massage, passive mobilization and physical exercises. Exp Hematol Oncol. 2017 Feb 7;6:5. doi: 10.1186/s40164-017-0065-6. eCollection 2017.