Clinical Research Directory

Multimodal Assessment of Cryotherapy for Paclitaxel-Induced Neuropathy

Female breast cancer patients receiving weekly paclitaxel-based chemotherapy are at risk of developing chemotherapy-induced peripheral neuropathy (CIPN), which may negatively affect quality of life and lead to treatment modifications or discontinuation. The aim of this clinical trial is to evaluate whether acral cryotherapy during chemotherapy administration can reduce the incidence and severity of CIPN. Participants receiving cryotherapy will be compared with participants receiving standard care without cryotherapy. During chemotherapy treatment and throughout the first year of follow-up, all participants will undergo serial evaluations of peripheral nerve function, including neurological examinations, nerve conduction studies, patient-reported quality-of-life questionnaires, and blood tests. In addition to routine laboratory testing, extra blood samples will be collected at two time points to assess biomarkers of nerve damage.

Self-applied taVNS for CIPN

The purpose of this study is to determine the feasibility of using a portable device at home to self-administer transcutaneous auricular vagus nerve stimulation (taVNS). This handheld device has two small electrodes that are placed on specific areas of the outer ear. This device delivers a mild electrical stimulation to the vagus nerve through the ear. This study will explore how taVNS may affect symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants will be assigned to one of two cohorts based on the presence of chemotherapy-induced peripheral neuropathy (CIPN). Participants with CIPN will be placed in the intervention cohort (n=24) and will complete a 2-week trial of daily self-applied taVNS. Participants without CIPN will be placed in the registry cohort (n=12) and will complete study measurements without receiving the intervention. The registry cohort will not receive the taVNS intervention but will undergo identical physiological assessments at baseline and at a 2 week follow up to control for testing effects and biological variability.

Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy

Taxane -induced peripheral neuropthy (TIPN) and nail toxicites are frequent side effects of taxane therapy in breast cancer patients.. TIPN involves the hands and the feet ,its symptoms comprise numbness,tingling,altered touch sensation, impaired vibration, parasthesia and dysesthesias induced by touch, warm or cool temperatures. This study investigate the preventive effect of TAR-0520 gel on TIPN and on nail toxicity. Breast cancer patients under taxanes therapy will apply TAR-0520 Gel to one hand and the homolateral foot including fingers and toes. Other hand and foot will be untreated and will serve as control. Patients will be followed during the 12 cycles of taxane therapy. Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaires administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of taxane nail toxicity will include a clinical grading by a nurse and a patient questionnaire.

Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device

The goal of this clinical trial is to examine a low-intensity, low-risk cranial PEMF device and its effectiveness with helping cancer patients manage neuropathy symptoms from chemotherapy. Eligible patients are individuals who have been diagnosed with chemotherapy-induced peripheral neuropathy or are experiencing pain due to chemotherapy and are eighteen to sixty. The main questions the study aims to answer are: To examine whether the application of low intensity, low frequency PEMF (by the System for Heterogeneous Integrated magnetic Field Transmission (SHIFT)) results in a significant decrease in neuropathic pain intensity. To examine if SHIFT results in a decrease of pain related interference and associated symptoms of CIPN. Researchers will compare an active, treatment arm to a placebo, SHAM arm. Participants will be required to use the device once daily, fill out daily, weekly, and monthly surveys. They will have to do one blood draw at the beginning of the study and one at the end of the study.

Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients

Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a prevalent and clinically relevant side effect of chemotherapy in breast cancer patients. It occurs in 30-70% of cases. It can cause various sensory and motor symptoms. Specific exercise interventions have proven promising to target relevant symptoms. Therefore, the objective of this study is to determine the effects of Sensorimotor training on pain intensity, perceived balance confidence, and functional exercise capacity with chemotherapy-induced peripheral neuropathy in breast cancer patients.

Effects of Telerehabilitation Versus Clinical Rehabilitation on Chemotherapy Induced Peripheral Neuropathy

The aim of this study is to determine the comparative effects of telerehabilitation versus clinical rehabilitation on neuropathic pain, physical function and quality of life in Chemotherapy induced peripheral neuropathy patients.