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
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
1 other identifier
observational
122
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedJuly 29, 2016
July 1, 2016
5.3 years
July 22, 2016
July 28, 2016
Conditions
Outcome Measures
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.
12 weeks
Study Arms (2)
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
Eligibility Criteria
Subjects with a haematological malinancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy.
You may qualify if:
- 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
You may not qualify if:
- psychiatric disorders
- plasmatic coagulation disorders
- thrombotic/thromboembolic events within 6 months before randomization
- severe neurological disorders like seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28194306DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 27, 2016
Study Start
June 1, 2010
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
July 29, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share