CIPN - Chemotherapy-Induced Peripheral Neuropathy

This research study is for people who have a condition called chemotherapy-induced peripheral neuropathy (CIPN). This condition develops as a result of receiving medication(s) to treat cancer, particularly chemotherapy. CIPN is characterized by pain, numbness, tingling or burning sensations, typically in the hands and feet of people. These symptoms can lead to physical suffering, limited ability to perform daily activities, and low quality of life. One of the ways to treat CIPN is using a device called Scrambler Therapy. Scrambler Therapy was approved by the Food and Drug Administration (FDA) in 2009 as a treatment for CIPN. The treatment involves electrical signals passing through wires attached to parts of the body via adhesive tabs near where symptoms of CIPN are experienced. A standard treatment course consists of 10 daily sessions lasting about one hour each. The purpose of this study is to determine the effect of a 10-day course of Scrambler Therapy on symptoms of chemotherapy-induced peripheral neuropathy, day-to-day activities, overall quality of life, and use of pain medications. Participants will be randomly assigned to one of two groups. One group will receive Scrambler Therapy. The other group will not receive it. Participants will not know which group they were in until after treatment has completed. Participants in the group who did not receive Scrambler Therapy will have the opportunity to receive it after one month. Participants will be in this research study about 12 to 14 months.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating complication among breast cancer survivors, frequently associated with chronic neuropathic pain that remains inadequately controlled by pharmacological treatments. Emerging evidence suggests that CIPN pain is related to maladaptive reorganization of pain-related brain networks, highlighting the potential of non-pharmacological, brain-based neuromodulation strategies. Among the variants of theta burst stimulation (TBS), both prolonged constant theta burst stimulation (pcTBS) and intermittent theta burst stimulation (iTBS) have facilitating effects of cortical excitability. The treatment time for pcTBS (1 min and 44 s, 1200 pulses) is much shorter than that of iTBS and traditional repetitive transcranial magnetic stimulation (rTMS); therefore, pcTBS seems to be a promising neuromodulation method for chronic pain and head-to-head comparison between pcTBS and iTBS has never been done before. The aim of this two-year randomized, cross-over trial project is 1) to compare the effects of pcTBS and iTBS and determine the optimal TBS paradigm for alleviating CIPN pain a sequential focus on distinct cortical targets; 2) to implement a prospectively defined, network-guided framework using fMRI to characterize sensorimotor and pain-related brain connectivity and to examine whether baseline network features and stimulation-induced connectivity changes moderate clinical outcomes. In Year 1, 20 breast cancer patients with CIPN will be recruited and randomly assigned to two groups: Group I will initially receive pcTBS over M1 for 5 consecutive days and then iTBS over M1 after a 8-week "wash-out" period. Group II will initially receive iTBS over M1 for 5 consecutive days and then pcTBS over M1 after a 8-week "wash-out" period. In year 2, the stimulation target will be changed to dorsolateral prefrontal cortex (DLPFC) to evaluate analgesic effects, and associated brain network changes related to cognitive-affective pain modulation. MRI-based neuronavigation will be used to ensure precise and reproducible stimulation targeting. Both resting-state and task-based functional MRI will be acquired before stimulation and used prospectively to identify individualized pain-relevant cortical hotspots within predefined anatomical regions (M1 or DLPFC). Resting-state fMRI will be repeated within 24 hours after the final stimulation session to evaluate treatment-related changes in brain networks. Pain intensity measured by the visual analog scale will serve as the primary outcome, with secondary outcomes including Neuropathic Pain Symptom Inventory, Depression Anxiety Stress Scale 21 and pressure pain threshold testing. Primary and secondary outcomes will be evaluated immediately after the last stimulation session and again at 4-week follow-up. By integrating a clinically efficient trial design with network-informed neuroimaging, this project is expected to provide target-specific evidence for TBS in CIPN pain and to establish a foundation for future precision-guided neuromodulation studies.

This Phase Ib clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of JMKX000189 tablets in participants with chemotherapy-induced peripheral neuropathy (CIPN).

This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. The name of the device used in this research study is: -Paxman Limb Cryocompression System (PLCS)

The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most prevalent side-effects of chemotherapy, causing sensory and motor symptoms in patients. CIPN development is especially prevalent in chemotherapy treatment involving platinum- and taxane-based agents. The accompanying pain and deficits greatly impact the quality of life of these patients. Currently, patients are assessed for altered somatosensory using quantitative sensory testing (QST). The German Research Network on Neuropathic Pain (DFNS) has developed a standardized protocol which has been internationally recognized as approach for performing the QST. However, for proprioception the QST is limited to vibration assessments, making it limited as the only test to measure proprioception. Therefore, a comprehensive assessment of the proprioceptive functions is needed to better understand the influence CIPN has on the proprioception of patients, and thereby their quality of life. In this project the effects of chemotherapy on somatosensory and proprioceptive functioning of breast cancer patients will be assessed in a cross-sectional study. This will be tested by comparing two groups of breast cancer patients and a healthy control group. Both patient groups will have undergone surgery for breast cancer, however, only one group will be tested after undergoing additional chemotherapy treatment. Thereby, the effects of chemotherapy between the surgery-only patient group and the chemotherapy patient group can tested. Furthermore, the investigators will compare both patient groups to sex- and age-matched healthy controls.

The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy results in improved levels of function as measured with the PDQ, and a decreased need for opioid medications. Our primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in achieving at least a 50% reduction in pain scores, when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline.

This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN). There will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN). Participants will: * Take drug duloxetine or a mirogabalin every day for 4 weeks. * Visit the clinic once every 2 weeks for checkups and tests

Due to well-proven survival benefit, paclitaxel and other taxane-based chemotherapies are first-line agents for both the adjuvant and neoadjuvant treatment of early stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of taxane anticancer agents. No established strategy exists for CIPN prevention. This study is designed to assess the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy in patients with breast cancer in a prospective randomized controlled trial.