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Completed

NCT Number: NCT05361018

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

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.

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Key information

Conditions

Breast Neoplasm, Exercise Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 11447, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole Body Vibration exercise - WBV

Other

participants will be randomised to two different training interventions

Other names: Conventional Aeorbic and Resistance exercise - CAR

Primary outcomes

  1. Chemotherapy-induced peripheral neuropathy subjective symptoms, less symptoms

    Time frame: Change from Baseline to 12 weeks

    Chemotherapy-induced peripheral neuropathy assessed by The Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) symptom experience scale

  2. Chemotherapy-induced peripheral neuropathy sensory loss assessment, increased sensation

    Time frame: 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

Secondary outcomes

  1. Balance control, improved balance

    Time frame: Change from Baseline to12 weeks

    Unipedal Stance Time test

  2. Performance status, improved balance and function

    Time frame: Change from Baseline to 12 weeks

    Timed Up and Go (TUG)

  3. Additional balance assessment

    Time frame: Change from Baseline to 12 weeks

    Modified Clinical Test for Sensory Interaction in Balance (mCTSIB)

  4. Pain related to CIPN, less pain than baseline

    Time frame: Change from Baseline to 12 weeks

    The painDETECT questionnaire

  5. Quality of Life assessment, improved quality of life

    Time frame: Change from Baseline to 12 weeks

    The EORTC-QLQ-C30 questionnaire

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: Sensi-Ex

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 4, 2022
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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