# Home-Based Physical Activity Intervention for Taxane-Induced CIPN

> **NIH NIH R01** · UNIVERSITY OF SOUTH FLORIDA · 2021 · $485,916

## Abstract

Project Summary/Abstract
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 16-
week 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.

## Key facts

- **NIH application ID:** 10225469
- **Project number:** 5R01CA229681-03
- **Recipient organization:** UNIVERSITY OF SOUTH FLORIDA
- **Principal Investigator:** CONSTANCE G. VISOVSKY
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $485,916
- **Award type:** 5
- **Project period:** 2019-09-19 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10225469

## Citation

> US National Institutes of Health, RePORTER application 10225469, Home-Based Physical Activity Intervention for Taxane-Induced CIPN (5R01CA229681-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10225469. Licensed CC0.

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