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

Not Applicable

Completed

• Conditions: Breast Neoplasm, Exercise

• Registration Number: NCT05361018
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-04
• Study Start: 2022-10-17
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chemotherapy-induced peripheral neuropathy sensory loss assessment, increased sensation	Change from Baseline to 12 weeks	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
Chemotherapy-induced peripheral neuropathy subjective symptoms, less symptoms	Change from Baseline to 12 weeks	Chemotherapy-induced peripheral neuropathy assessed by The Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) symptom experience scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden