University Of South Florida
Early Stage Investigator Grants (ESI)
Project End Date
For more information, see NIH RePORTER Project 5R01CA229681-04
Home-Based Physical Activity Intervention for Taxane-Induced CIPN
Persistent taxane-induced peripheral neuropathy is a significant dose-limiting toxicity of breast cancer treatment with chemotherapy. The sensory and motor neuron dysfunction accompanying taxane chemotherapy results in sensory and motor neuropathy by inducing both mitochondrial and vascular dysfunction, impairing physical functioning, and quality of life. The specific aims of this 2-group RCT are: 1)to test the efficacy of a 16week gait and balance training plus resistance exercise, compared to an educational attention control condition in decreasing the severity of taxane-induced peripheral neuropathy symptoms; and 2) to evaluate for differences in gait/balance, lower extremity muscle strength, sensory (sural) and motor (peroneal) nerve conduction, and quality of life (QOL) between patients who receive the gait/balance training plus resistance exercise program, compared to those in an educational attention control condition controlling for age, BMI, taxane cycles/interval, neuropathic pain, medications (pain or neuropathy-specific medication), current resistance exercise, and falls/near falls experienced. This RCT will enroll a sample of 312 patients who completed a taxane-containing chemotherapy regimen for breast cancer > 1 year who have a neuropathy score of > 3 on a CIPN visual analog scale. Assessments of lower extremity muscle strength, gait/balance, nerve conduction, neuropathy symptoms, and quality of life (QOL) will be collected at baseline (prior to randomization); 4 weeks; 8 weeks; 12 weeks; and 16 weeks. Nerve conduction studies will be performed at baseline (pre-intervention) and 16 weeks (end of intervention). Control variables of age, BMI, taxane cycles/interval, and current resistance exercise will be collected at baseline. Data regarding neuropathic pain, medications (pain or neuropathy-specific medication), and falls/near falls will be assessed at each data collection time point for their influence upon the dependent variables. Following baseline data collection, participants will be randomly assigned to the combination gait/balance plus resistance training intervention or the education attention control group. Data analysis will consist of an intention to treat analytic strategy utilizing a generalized mixed modeling framework.
|Study Name||Clinical Trial ID|
|Home-Based Physical Activity Intervention for Taxane-Induced CIPN||NCT04621721|