Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor

Status Completed

Clinical Trial Summary

Chemotherapy-induced peripheral neurotoxicity (CIPN) as a side effect of chemotherapy negatively affects patients' quality of life and may lead to treatment disturbances. CIPN is frequently recorded in patients treated with alkylating platinum-based drugs, antitubulins including the taxanes and vinca alkaloids, and other drugs including suramin, thalidomide, lenalidomide and the proteasome inhibitor bortezomib, representing one of the most severe and potentially dose-limiting non-hematological toxic effects. Sufficient treatment options or preventive measures are lacking.

There is evidence that physical activity strategies are able to address existing CIPN symptoms and potentially increase quality of life in affected patients. CIPN symptoms involves restrictions of sensory and sometimes motor modalities, for example, deficits in plantar perception and dysfunction of postural control and one study in type II diabetes patients also suggested that structured exercise might have a preventive potential with regard to peripheral neuropathy incidence.

Based on these findings, we aim to investigate the preventive potential of a sensorimotor intervention vs. machine-based resistance training vs. usual care (wait-list control group) in a randomized controlled three-arm intervention trial among cancer patients undergoing chemotherapy with high risk for CIPN. On the basis of power calculations, the goal is to include 82 patients per intervention arm resulting in a total patients number to be enrolled of n=246. CIPN symptoms will be assessed objectively via comprehensive clinical and electrodiagnostic examinations (Total Neuropathy Scale; TNS-reduced) and subjectively via questionnaires (EORTC QLQ-CIPN20 & FACT-GOG-Ntx, EORTC QLQ-C30). Additionally CIPN and the effectiveness of the selected interventions will be objectively evaluated by spectral analysis of Centre of Pressure (COP) variations. Further key secondary endpoints are: physical performance, sleep quality and chemotherapy compliance.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02871284
Study type	Interventional
Source	German Cancer Research Center
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	December 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05156424` - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer	Phase 1/Phase 2
Completed	`NCT05108181` - Muscle Typology and Strength Training Adaptations	N/A
Recruiting	`NCT05052918` - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes	N/A
Completed	`NCT04508270` - Significance of Early Mobilization After VATS-L
Recruiting	`NCT04994340` - Physical Activity Observatory of Castilla-La Mancha
Completed	`NCT04815980` - Impact of Pilates on Running Mechanics	N/A
Completed	`NCT05189795` - The Construction of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
Completed	`NCT03683758` - Effects of the FIFA11+ Warm-up Program on Speed, Agility, and Vertical Jump Performance in Adult Female Amateur Soccer Players	N/A
Completed	`NCT05538520` - Effects of Pilates Stretching on Flexibility, Strength, Power and Muscular Endurance	N/A
Completed	`NCT06315036` - Effects of Developmental Gymnastics on Preschoolers' Motor Skills	N/A
Completed	`NCT03171064` - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment	Phase 2
Recruiting	`NCT05496751` - Response Variability to Exercise	N/A
Not yet recruiting	`NCT05029804` - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes	N/A
Completed	`NCT04207359` - Effects of Creatine Supplementation in Breast Cancer Survivors	N/A
Completed	`NCT03832205` - Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
Completed	`NCT04099654` - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery	N/A
Completed	`NCT03297567` - Physical Therapy Guidelines For Hospitalized Elderly	N/A
Completed	`NCT03477188` - The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke.	N/A
Recruiting	`NCT05956327` - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training	N/A
Recruiting	`NCT06018311` - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training — PIC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms