Clinical trial NCT05361018: Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm, Exercise
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Chemotherapy-induced peripheral neuropathy subjective symptoms, less symptoms
timeFrame: Change from Baseline to 12 weeks
measure: Chemotherapy-induced peripheral neuropathy sensory loss assessment, increased sensation
timeFrame: Change from Baseline to 12 weeks
Secondary outcomes:
measure: Balance control, improved balance
timeFrame: Change from Baseline to12 weeks
measure: Performance status, improved balance and function
timeFrame: Change from Baseline to 12 weeks
measure: Additional balance assessment
timeFrame: Change from Baseline to 12 weeks
measure: Pain related to CIPN, less pain than baseline
timeFrame: Change from Baseline to 12 weeks
measure: Quality of Life assessment, improved quality of life
timeFrame: Change from Baseline to 12 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Yvonne Wengström, Professor
role: PRINCIPAL_INVESTIGATOR
References: