CIPN is induced by neurotoxic chemotherapeutic agents and manifests with sensory and/or motor deficits. It is associated with significant disability and poor recovery. Common symptoms include pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control and insecure gait. The purpose of the study is to compare effects of sensory vibrations training to conventional aerobic and strenght exercise on neurophatic symptoms related to chemotherapy treatment.
Aim: To (a) compare the effects of WBV exercise compared to regular cardiovascular and resistance exercise (CAR) on the primary outcome of (a) CIPN symptoms and secondary outcomes of (b) balance, physical function, and quality of life. Based on previous pilot study findings, we hypothesize that WBV exercise compared to CAR will reduce relevant symptoms to a larger degree, such as the loss of peripheral deep sensitivity, pain, weakened or absent reflexes and loss of balance control (aim a) and that patients will experience an improvement in physical function and quality of life (aim b). The study employs a prospective, multicenter, two-armed, randomized controlled design. Study participants will be informed about the study procedure and sign a written informed consent. Patients will then be assigned randomly either to the WBV group or the CAR group. Patients allocated to the WBV group receive a defined WBV exercise program twice a week in addition to their usual treatment. Patients in conventional aerobic and resistance exercise (CAR) group will receive a defined exercise program twice a week in addition to their usual treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
44
participants will be randomised to two different training interventions
Karolinska University Hospital
Stockholm, Sweden
Chemotherapy-induced peripheral neuropathy subjective symptoms, less symptoms
Chemotherapy-induced peripheral neuropathy assessed by The Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) symptom experience scale
Time frame: Change from Baseline to 12 weeks
Chemotherapy-induced peripheral neuropathy sensory loss assessment, increased sensation
Monofilament testing will be performed to further quantify sensory loss at all three time points by a specially trained researcher with Von Frey Monofilament Kit using established procedures by Dyck and colleagues
Time frame: Change from Baseline to 12 weeks
Balance control, improved balance
Unipedal Stance Time test
Time frame: Change from Baseline to12 weeks
Performance status, improved balance and function
Timed Up and Go (TUG)
Time frame: Change from Baseline to 12 weeks
Additional balance assessment
Modified Clinical Test for Sensory Interaction in Balance (mCTSIB)
Time frame: Change from Baseline to 12 weeks
Pain related to CIPN, less pain than baseline
The painDETECT questionnaire
Time frame: Change from Baseline to 12 weeks
Quality of Life assessment, improved quality of life
The EORTC-QLQ-C30 questionnaire
Time frame: Change from Baseline to 12 weeks
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