A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
This trial studies treatment effects on development of chemotherapy-induced peripheral neuropathy in patients with cancer. Treatments for cancer can cause a problem to the nervous system (called peripheral neuropathy) that can lead to tingling or less feeling in hands and feet. Studying certain risk factors, such as age, gender, pre-existing conditions, and the type of treatment for cancer may help doctors estimate how likely patients are to develop the nerve disorder.
NCT03939481 — Anatomic Stage III Breast Cancer AJCC v8
Status: Active, not recruiting
http://inclinicaltrials.com/anatomic-stage-iii-breast-cancer-ajcc-v8/NCT03939481/
A Study of Diffusion Tensor Imaging of Median Nerve in Diabetic Peripheral Neuropathy
This study is a diagnostic accuracy study that aims to evaluate the role of DTI in evaluation of DPN in comparison to clinical scores and nerve conduction studies (NCS). The study included 30 patients with diabetes mellitus complaining of neuropathy symptoms and 15 healthy volunteers. All subjects underwent evaluation using 1.5T DTI of median nerves and NCS. Patients underwent clinical evaluation using Neuropathy Deficit Score (NDS), Neuropathy Impairment Score in the Lower Limbs (NIS-LL) and Diabetic Neuropathy Examination (DNE) score. The values of these tests were compared and correlated and diagnostic accuracy tests were performed together with identification of cut-off score for abnormal diffusion tensor imaging parameters in diabetic neuropathy
NCT03934970 — Magnetic Resonance Imaging
Status: Completed
http://inclinicaltrials.com/magnetic-resonance-imaging/NCT03934970/
Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study: From Proper Assessment to Trial Needs - IMAGiNe Study-Lyon/Bicêtre
There is no international consensus regarding how to assess and treat patients with immunoglobulin M (IgM)-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy associated peripheral neuropathy. The purpose of the IMAGiNe study-Lyon/Bicêtre is to prospectively collect standardized clinical data of 25 patients with IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy in order to participate in the international IMAGiNe Study. The main objective is to describe in detail the various clinical subtypes, clinical course, treatment responses, antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures. The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale (RODS) that should fulfill all modern clinimetric requirements, including cross-cultural validity. The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht, both in the Netherlands.
NCT03918421 — Immunoglobin M Anti-myelin-associated-glycoprotein Peripheral Neuropathy
Status: Recruiting
http://inclinicaltrials.com/immunoglobin-m-anti-myelin-associated-glycoprotein-peripheral-neuropathy/NCT03918421/
Exploration Of The Sensitivity And Specificity Of The Pressure-Specified Sensory Device™ (PSSD) For Chemotherapy-Induced Peripheral Neuropathy
Problem: A significant proportion of patients with cancer experience symptoms of sensory, motor or autonomic nerve damage from chemotherapy known as chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a major dose-limiting toxicity of many chemotherapeutic regimens. Little is known about the natural history of CIPN, and the early detection and quantification of CIPN is a significant challenge. Design: The investigators propose a cohort study to evaluate the performance of the Pressure-Specified Sensory Device TM (PSSD) in assessing CIPN associated with various common chemotherapy regimens. The proposed study will examine peripheral nerve function before, during, and after chemotherapy treatment. Peripheral neuropathy will be assessed using the PSSD, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN-20, and the Michigan Neuropathy Screening Instrument (MNSI). These are all established and validated methods to screen for a variety of conditions that cause peripheral neuropathy. Hypotheses: The investigators hypothesize that the PSSD will be a sensitive and specific tool for measuring CIPN. The onset of CIPN as detected by the PSSD will be compared with other screening modalities including the EORTC QLQ-CIPN20 and the MNSI. Importance: The development of CIPN often goes unnoticed until symptoms are bothersome. Having an objective tool in the care team's armament to screen for CIPN could have a significant public health impact.
NCT03909464 — Cancer
Status: Completed
http://inclinicaltrials.com/cancer/NCT03909464/
A Randomized Phase II Pilot Clinical Trial of Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
The goal of this clinical research study is to learn if one acupuncture treatment approach is more effective than another in helping to relieve chemo-therapy induced neuropathy in cancer patients. If eligible to take part in this study, participants will be randomly assigned to 1 of 2 groups - group 1 participants will receive traditional acupuncture treatments 2 times a week for a total of 20 sessions. Group 2 participants will have acupuncture sessions with electrical stimulation 2 times a week for a total of 20 sessions.
NCT03881748 — Peripheral Neuropathy
Status: Withdrawn
http://inclinicaltrials.com/peripheral-neuropathy/NCT03881748/
Cryocompression for Bortezomib-Induced Peripheral Neuropathy Among Multiple Myeloma Patients
This trial studies how well cryocompression therapy works in reducing bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Peripheral neuropathy (nerve pain or tingling in hands or feet) is a common side effect of chemotherapy such as bortezomib that affects the quality of life and amount of chemotherapy that can be given to many cancer patients. Cryocompression is a treatment where a glove and a boot are worn to cool down the skin. This cooling treatment is safe and does not interfere with chemotherapy treatment. Daily cryocompression therapy may reduce neuropathy caused by bortezomib chemotherapy.
NCT03870451 — Chemotherapy-induced Peripheral Neuropathy
Status: Terminated
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT03870451/
The Effects of Exercise and Nutrition Interventions on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
NCT03858153 — Neuropathy;Peripheral
Status: Recruiting
http://inclinicaltrials.com/neuropathy-peripheral/NCT03858153/
Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy
Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic. Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects. All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).
NCT03847779 — Vasodilation
Status: Completed
http://inclinicaltrials.com/vasodilation/NCT03847779/
Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study
This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.
NCT03824860 — Chronic Pain
Status: Completed
http://inclinicaltrials.com/chronic-pain/NCT03824860/
A Randomized Phase II Study Comparing Lorcaserin Versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
A Randomized Phase II study Comparing Lorcaserin versus Duloxetine for the Treatment of Chemotherapy-Induced Peripheral Neuropathy Produced by Oxaliplatin
NCT03812523 — Chemotherapy-Induced Peripheral Neuropathy
Status: Not yet recruiting
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT03812523/