- ICH GCP
- US Clinical Trials Registry
- 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
July 28, 2016 updated by: Prof. Dr. Richard Schlenk, University of Ulm
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
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).
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
122
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with a haematological malinancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group A
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Group B
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• 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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
July 22, 2016
First Submitted That Met QC Criteria
July 22, 2016
First Posted (Estimate)
July 27, 2016
Study Record Updates
Last Update Posted (Estimate)
July 29, 2016
Last Update Submitted That Met QC Criteria
July 28, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI-PNP - _01_10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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