Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy (Sensi-Ex)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm, Exercise
• Intervention / Treatment: Other: Whole Body Vibration exercise - WBV

Detailed Description

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
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11447
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole Body Vibration exercise - WBV; 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; participants will be randomised to two different training interventions; Other Names: Conventional Aeorbic and Resistance exercise - CAR
Active Comparator: Conventional Aerobic and Resistance exercise - CAR; 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; participants will be randomised to two different training interventions; Other Names: Conventional Aeorbic and Resistance exercise - CAR

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Yvonne Wengström, Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Skin Diseases; Breast Diseases; Breast Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: Yvonne Wengstrom

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No