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

Polyneuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846844
• Other study ID #: PI-PNP - _01_10
• Status: Completed
• Phase: N/A
• First received: July 22, 2016
• Last updated: July 28, 2016
• Start date: June 2010
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polyneuropathies
• Polyneuropathy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No