Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SensiEx - Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy After Treatment for Breast Cancer a Randomized Controlled Pilot Trial

Conditions
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Breast Neoplasm, Exercise

Intervention / Treatment
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* Other: Whole Body Vibration exercise - WBV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with breast cancer, aged 18-80 years, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, completed chemotherapy in the past 3 months. Experiencing symptoms of CIPN Exclusion Criteria: pre-existing neuropathy of other cause (eg, diabetes), given contraindications for WBV including instable bone metastases and severe cardiovascular disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two-armed, randomized controlled design. 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole Body Vibration exercise - WBV<br>The vibration exercises take place on a tri-planar vibration platform (Power Plate) according to the initially determined setting for each individual (highest, though feasible neuromuscular response). . Each session lasts for about 15-30 min in total, leaving sufficient time for regeneration. Training consists of at least four vibration exercises, chosen from a standardized pool of exercises with increasing difficulty in order to allow for individual, optimal progression. All sessions and adherence are documented by the exercise supervisor. Adverse events are documented, and patients asked to give feedback regarding the feasibility and subjective impression of each individual setting. All training sessions will be supervised. The participants rating of perceived exertion (RPE) will be assessed immediately after each set of exercise. | Other: Whole Body Vibration exercise - WBV<br>* participants will be randomised to two different training interventions<br>* Other names: Conventional Aeorbic and Resistance exercise - CAR;|
| Active Comparator: Conventional Aerobic and Resistance exercise - CAR<br>exercise sessions commence with 20 min of moderate intensity continuous aerobic exercise at a rating of perceived exertion (RPE) of 13-15 on the Borg scale. Participants complete both resistance exercises and high intensity intermittent aerobic exercises during each session. The resistance training regimen consists of 8 exercises (leg press, biceps curls, triceps extensions, bench press, shoulder press, standing row, sit ups/Russian weighted abdominal twist, and prone lying back extensions. Participants complete 2 sets of 8-12 repetitions at an initial intensity of 70 % of their estimated 1 repetition maximum (1-RM) strength and increase to 80 % of estimated 1-RM when more than 12 repetitions can be correctly performed by the participant | Other: Whole Body Vibration exercise - WBV<br>* participants will be randomised to two different training interventions<br>* Other names: Conventional Aeorbic and Resistance exercise - CAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Change from Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance control, improved balance | Unipedal Stance Time test | Change from Baseline to12 weeks | 
| Performance status, improved balance and function | Timed Up and Go (TUG) | Change from Baseline to 12 weeks | 
| Additional balance assessment | Modified Clinical Test for Sensory Interaction in Balance (mCTSIB) | Change from Baseline to 12 weeks | 
| Pain related to CIPN, less pain than baseline | The painDETECT questionnaire | Change from Baseline to 12 weeks | 
| Quality of Life assessment, improved quality of life | The EORTC-QLQ-C30 questionnaire | Change from Baseline to 12 weeks |