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

Completed

• Conditions: Polyneuropathy

• Registration Number: NCT02846844
• Lead Sponsor: University of Ulm

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).

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-07
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• 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