CN71 - SensiEx: A randomized pilot trial Sensorimotor training using whole body vibration exercise to reduce chemotherapy-induced peripheral neuropathy after treatment for breast cancer

Background

Approximately 50% of women receiving chemotherapy for breast cancer develop chemotherapy induced peripheral neuropathy (CIPN) and is associated with significant disability and poor recovery. Common symptoms of CIPN include pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control and insecure gait. These symptoms affect activities of daily living and reducing patients' quality of life. CIPN also cause treatment delays, dose reductions, or even discontinuation of therapy, which can affect the outcome and compromise survival. To date, CIPN cannot be prevented and effective treatment options are lacking. Preliminary data indicate that whole body vibration (WBV) exercise may have a preventive effect on the onset of CIPN. However, how WBV compares to conventional cardio and resistance exercise (CAR) exercise for alleviate CIPN has not yet been studied. The aim is to compare the effects of WBV exercise compared to CAR on the primary outcome of CIPN symptoms and secondary outcomes of balance, physical function, and quality of life.

Methods

This prospective, multicenter, two-armed, randomized pilot study will include 44 women, assigned randomly either to the WBV group or the CAR group. Patients will exercise twice per week (at Karolinska) for 12 weeks. Measurements are performed at baseline, 3 and 6 months. Inclusion criteria: breast cancer diagnosis, aged 18–65 years, ECOG performance status of 0–2, completed chemotherapy in the past 6 month and remaining CIPN symptoms. Exclusion criteria: pre-existing neuropathy of other cause, severe cardiovascular disease, regular intake of analgesics, smoking. Measurement: CIP-NAT, CIPN-R-ODS, QLQ-C30, PainDETECT, Monofilament, Turn fork test, Tendon reflexes, Balance and Muscle strength tests.

Results

Based on previous study findings, we hypothesize that WBV exercise compared to CAR will reduce symptoms to a larger degree, such as the loss of peripheral deep sensitivity, pain, weakened or absent reflexes and loss of balance control.

Conclusions

Hopefully patients will experience an improvement in physical function and quality of life.

Clinical trial identification

NCT05361018.

Editorial acknowledgement

Legal entity responsible for the study

Y. Wengström.

Funding

Swedish Breast Cancer Association.

Disclosure

All authors have declared no conflicts of interest.