SensiEx - Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy After Treatment for Breast Cancer a Randomized Controlled Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Chemotherapy-induced peripheral neuropathy sensory loss assessment, increased sensation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Additional balance assessment(Change from Baseline to 12 weeks)
- Pain related to CIPN, less pain than baseline(Change from Baseline to 12 weeks)
- Performance status, improved balance and function(Change from Baseline to 12 weeks)
- Balance control, improved balance(Change from Baseline to12 weeks)
- Quality of Life assessment, improved quality of life(Change from Baseline to 12 weeks)
Investigators
Yvonne Wengstrom
Professor
Karolinska Institutet