Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most challenging and complex complications of cancer chemotherapy. Although incidence of CIPN varies among drug class, approximately 30-40% of cancer patients will be affected. Among various CIPN-related symptoms, loss of balance and walking difficulty have been identified as leading risk factors for falls. Given the high number of CIPN patients suffering from balance and gait deficits, surprisingly appropriate assessment and treatment strategies for these deficits have not been adequately developed. Current assessment of balance and gait is based on subjective rating scales which may not be accurate for estimation of fall risk and adjustment of chemotherapy dosage. Objective and clinically feasible assessment tools are lacking. Additionally, there is a lack of exercise regimes that take into account the specific CIPN related sensational deficits. CIPN patients may require uniquely designed training approaches to help compensate for these deficits. To our knowledge, no CIPN-specific balance training program has been evaluated. The primary innovation of the proposed research project is the application of a validated, wearable technology for 1) objectively assessing CIPN-related balance and gait deficits to examine the development and severity of CIPN and its association with changes in balance and gait during a period of 6 months chemotherapy treatment; and 2) evaluate the feasibility of a technology-based exercise training for improving balance and gait performance. The exercise provides an interactive sensor-based interface including real-time joint movement- feedback from lower extremity joint motion. We will conduct two clinical studies for validating/ evaluating our proposed assessment and treatment strategy. Clinical study 1 is a longitudinal study in which we will evaluate the association between CIPN and balance/ gait as measured by wearable sensor-based assessment. Sixty (60) cancer patients receiving neurotoxic chemotherapy will undergo assessment of gait and balance every two months over a period of 6 months. Additionally, development and severity of CIPN as quantified by Vibratory Perception Threshold (VPT) test and clinical examination will be obtained and fall occurrence will be monitored. Clinical study 2 is a double blinded randomized controlled trial for evaluating the effectiveness of an innovative technology-based exercise training program for improving gait and balance, and preventing falls in CIPN patients. We will randomly assign 66 eligible subjects with confirmed CIPN into a control group and intervention group and follow them for six months. The intervention group will take part in a 6-week balance training program using the proposed technology twice per week in their home. Control group will be instructed to complete a supervised validated program of non-technology home-based exercises twice per week for six weeks. We will compare the effectiveness of the intervention between groups based on quantifiable changes in balance, gait, quality of life, physical activity and risk of falling betwen pre- and post-intervention assessments.

Public Health Relevance

Cancer patients suffering from chemotherapy-induced peripheral neuropathy (CIPN) have a significantly higher risk of falling than their peers due to insensitivity in the lower extremities causing deficits in keeping balance during standing and walking; however, appropriate exercise training programs for these patients have not been developed. Conventional fall prevention training may not be well suited for these patients because 1) the exercises may be too difficult; and 2) many existing exercises do not incorporate visual feedback, which is critical, given the impaired proprioception associated with peripheral neuropathy. We propose to evaluate a system consisting of wearable movement sensors and software that provides visual feedback of lower extremity position in a game-based, motivational, virtual environment to facilitate performance of specific exercises in cancer patients exposed to neurotoxic chemotherapy to mitigate CIPN- induced balance problems and increased fall risk.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21CA190933-01A1
Application #
9023922
Study Section
Special Emphasis Panel (ZCA1-SRB-2 (O1))
Program Officer
O'Mara, Ann M
Project Start
2016-03-14
Project End
2018-02-28
Budget Start
2016-03-14
Budget End
2017-02-28
Support Year
1
Fiscal Year
2016
Total Cost
$259,412
Indirect Cost
$95,745
Name
Baylor College of Medicine
Department
Surgery
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030