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CompletedNCT02846844Updated Jul 29, 2016

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

An observational study in Polyneuropathy, sponsored by University of Ulm. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-07-29.

Sponsored by University of Ulm · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Ages
18 Years to 70 Years
Sex
All
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Study 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).

Read the 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).

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Conditions studied

  • Polyneuropathy

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03

In context

Polyneuropathies

256 studies on the registry are indexed under Polyneuropathies; 50 are open to participants now.

This study's enrollment of 122 is above the median of 100 across 75 observational studies indexed under Polyneuropathies.

Browse Polyneuropathies studies →

Lead sponsor

University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with a haematological malinancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A

    * Whole body vibration training * manuelle therapy * exercises for power and coordination * performance training as needed

  • Group B

    * manuelle therapy * Exercises for power and coordination * Performance training as needed

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 28194306 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02846844
Lead sponsor
University of Ulm
Responsible party
Prof. Dr. Richard Schlenk (Prof. Dr., University of Ulm) — Principal investigator
First posted
Jul 27, 2016
Start date
Jun 2010
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Jul 29, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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