Fall Risk Associated with Taxanes: Focus on Chemotherapy-Induced Peripheral Neuropathy.

OBJECTIVES: Chemotherapy-induced peripheral neuropathy (CIPN) remains a significant toxicity for women with breast cancer receiving taxane-based treatment. This analysis has been done within the context of an ongoing 16-week randomized clinical trial consisting of a gait, balance, and strength training exercise intervention for the lower extremities in women with persistent CIPN who received taxane-based chemotherapy for breast cancer. The aim of this analysis is to determine the baseline fall risk among 62 study participants with persistent taxane-induced CIPN assigned to the control group. METHODS: This analysis used the baseline demographic, medical data, nerve conduction, gait, balance, and muscle strength variables of participants prior to randomization to develop an explanatory model of fall risk. The analytic approach utilized generalized linear modeling with Lasso to select baseline risk factors for future falls. RESULTS: Characteristics of the study sample by intervention and control group revealed no significant differences between the groups at baseline. The only baseline risk factors that were significantly associated with future falls were near falls within the last month (ß = 0.90, P = .056) with an odds ratio = 2.46, 95% confidence interval 0.31 to 17, and right ankle plantar flexion torque. (ß = 0. 05, P = .006) with an odds ratio = 1.05, 95% confidence interval 1.01 to 1.10. Demographic and medical data, nerve conduction parameters, gait, balance, or muscle strength variables did not significantly influence fall risk in this population. CONCLUSIONS: The potential for injury and disability from falls is a considerable concern among oncology clinicians and women with breast cancer and persistent CIPN. While falls and fall risk have been previously examined in other studies of breast cancer survivors, the majority of studies fail to capture the occurrence of "near falls" a significant predictor of fall risk. In addition, it is possible that ankle strength may prove to be a potential target for fall prevention in this population. Evidence-based interventions focused on improving neuropathic symptoms, physical function, and quality of life in persons with CIPN are still needed. IMPLICATION FOR NURSING PRACTICE: Oncology nurses and nurse practitioners should query patients who received taxane-based chemotherapy for not only the incidence and frequency of falls but the occurrence of near falls. A prompt referral to physical therapy may be useful in strengthening the lower extremities to improve balance and prevent falls.

Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for persistent taxane-induced peripheral neuropathy (B-HAPI study): a randomized controlled trial.

BACKGROUND: Evaluation publications typically summarize the results of studies to demonstrate the effectiveness of an intervention, but little is shared concerning any changes implemented during the study. We present a process evaluation protocol of a home-based gait, balance, and resistance exercise intervention to ameliorate persistent taxane-induced neuropathy study according to 7 key elements of process evaluation. METHODS: The process evaluation is conducted parallel to the longitudinal, randomized control clinical trial examining the effects of the home-based gait, balance, and resistance exercise program for women with persistent peripheral neuropathy following treatment with taxanes for breast cancer (IRB approval: Pro00040035). The flowcharts clarify how the intervention should be implemented in comparable settings, fidelity procedures help to ensure the participants are comfortable and identify their individual needs, and the process evaluation allows for the individual attention tailoring and focus of the research to avoid protocol deviation. CONCLUSIONS: The publication of the evaluation protocol plan adds transparency to the findings of clinical trials and favors process replication in future studies. The process evaluation enables the team to systematically register information and procedures applied during recruitment and factors that impact the implementation of the intervention, thereby allowing proactive approaches to prevent deviations from the protocol. When tracking an intervention continuously, positive or negative intervention effects are revealed early on in the study, giving valuable insight into inconsistent results. Furthermore, a process evaluation adds a participant-centered element to the research protocols, which allows a patient-centered approach to be applied to data collection. TRIAL REGISTRATION: ClinicalTrials.gov NCT04621721, November 9, 2020, registered prospectively. PROTOCOL VERSION: April 27, 2020, v2.

Home-Based Pilot Pulmonary Program for Dyspneic Patients Post-COVID-19.

It is estimated that at least 10% of people who have had COVID-19 will experience ongoing symptoms such as shortness of breath, fatigue, and cognitive disturbances. Pulmonary exercise has demonstrated improved dyspnea outcomes in other respiratory conditions. Thus, the purpose of this study was to assess the efficacy of a home-based pulmonary rehabilitation program in post-COVID-19 survivors who continue to experience dyspnea. This was a longitudinal, single group pilot study in which 19 patients received a home-based expiratory muscle strength training program over 12 weeks. Outcomes measured at baseline, 6 weeks, and 12 weeks included pulmonary symptoms, functional performance, thoracic expansion, forced expiratory volume, and expiratory resistance measures. Significant improvements were found in pulmonary symptoms (p < .001), functional performance (p = .014), and progressive expiratory resistance capabilities (p < .001). A home-based pulmonary program may be an inexpensive strategy for post-COVID-19 survivors who continue to experience dyspnea.

Assessing gait, balance, and muscle strength among breast cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): study protocol for a randomized controlled clinical trial.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and understudied consequence of taxane chemotherapy for breast cancer treatment. CIPN symptoms include numbness combined with tingling sensations, persistent shooting, stabbing, or burning pain even in the absence of painful stimuli, lower extremity muscle weakness, and impaired balance. CIPN symptoms often persist for a long time after completion of chemotherapy, causing significant loss of functional abilities and increased risk of falls. Persistent CIPN caused by taxanes represents a therapeutic challenge due to the limited treatment options. Resistance exercise has shown promising results; however, the effect of exercise on CIPN remains understudied. This study aims to assess the effects of exercise on gait, balance, and lower extremity muscle strength after a 16-week home-based exercise program compared to an educational attention control condition. METHODS: A sample of 312 women who completed taxane-based chemotherapy for breast cancer and have symptomatic neuropathy is recruited from a community-dwelling sample. Participants are randomized to either a 16-week Home-Based Physical Activity Intervention or an Educational Attention control group. The home-based intervention protocol consists of targeted lower extremity stretches, followed by 10 min each of gait/balance and 10 min of resistive training accessed by hyperlink or DVD. An Exercise Diary records quantitative exercise data. The gait assessment includes temporospatial parameters and lower extremity joint angles using APDM motion sensors. Participants' balance is assessed using the Sensory Organization Test (SOT) performed using a NeuroCom Balance Master. Isometric strength of hip, knee, and ankle flexor and extensor muscles is assessed using an isokinetic dynamometer, Biodex BX Advantage. In addition, we assess neuropathy symptoms using the FACT-Taxane Additional Concerns Subscale and nerve conduction velocity of the sural and peroneal nerve action potentials. Outcomes are assessed at baseline (prior to randomization) and 16 weeks. DISCUSSION: There are currently no evidence-based interventions that address the functional declines associated with CIPN. If successful, this program is simple and easy to implement in the standard of care for individuals with CIPN. Gait and balance training have the potential to reduce physical dysfunction associated with CIPN and reduce the burden of disease in cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov NCT04621721 . Registered on August 3, 2020. ClincialTrials.gov is a primary registry of the World Health Organization International Clinical Trials Registry Platform (WHO ICTEP) network and includes all items from the WHO Trial Registration data set in Trial registration.