Breast Neoplasm, Exercise
Conditions
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.
Interventions
OTHERWhole Body Vibration exercise - WBV
participants will be randomised to two different training interventions
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional balance assessment | Change from Baseline to 12 weeks | Modified Clinical Test for Sensory Interaction in Balance (mCTSIB) |
| 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 |
| 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) |
Countries
Sweden
Outcome results
None listed