Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.
NCT03031834 — Diabetic Autonomic Neuropathy
Status: Completed
http://inclinicaltrials.com/diabetic-autonomic-neuropathy/NCT03031834/
Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)
Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective, multicenter cohort study conducted to characterize and determine the incidence of eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of eribulin-induced PN in adult participants treated with eribulin in a real-life setting with locally advanced or metastatic breast cancer (MBC) who have progressed following at least one and up to three chemotherapeutic regimens for advanced disease.
NCT03027245 — Locally Advanced or Metastatic Breast Cancer
Status: Completed
http://inclinicaltrials.com/locally-advanced-or-metastatic-breast-cancer/NCT03027245/
Assessment of Sensory Disorders Associated With Peripheral Neuropathy Induced by Bortezomib: Prospective Comparative Study
Chemotherapy-induced peripheral neuropathies (CIPN) remain a problem in oncology because no "gold standard" treatment exists to prevent or treat the CIPN. Therefore, oncologists reduce or stop the chemotherapy doses to limit degradation of the quality of life of patients with CIPN. Bortezomib is relatively understudied while neurotoxicity remains a limiting factor for treatment. Since 2012, the FDA and the EMA validated by the administration of bortezomib subcutaneously (SC) instead of intravenous (IV) in order to limit neurotoxicity. However, a retrospective study reported that the prevalence of neuropathy induced by bortezomib after SC administration remains high and equivalent to IV route. No studies have quantitatively and qualitatively evaluated the sensory disorders in peripheral neuropathies induced by bortezomib after SC administration. On the other hand, the QLQ-CIPN20 questionnaire (EORTC) evaluating the intensity of sensory, motor and autonomic disorders associated with CIPN has never been tested in this population. The objective of this study is twofold: (i) psychophysical evaluation of neuropathic disorders by studying the thermal and vibratory detection thresholds and thermal nociceptive thresholds and (ii) quantitative and qualitative assessment of neuropathic disorders by the QLQ-CIPN20 and related comorbidities in a population of neuropathic patients treated with bortezomib (n = 15), compared to control patients treated with bortezomib but non-neuropathic (n = 45).
NCT02976272 — Multiple Myeloma
Status: Recruiting
http://inclinicaltrials.com/multiple-myeloma/NCT02976272/
A Randomized, Double-blind, Placebo-Controlled, Cross-over Study on the Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy
The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the level of pain associated with walking. Consequently, it is hypothesized that the reduction in pain will result in an increase in the amount of walking they do during the day, improvements in their gait, balance, risk of falls and sleep patterns.
NCT02927951 — Diabetic Peripheral Neuropathy
Status: Completed
http://inclinicaltrials.com/diabetic-peripheral-neuropathy/NCT02927951/
Neuroprotective Effect of Vitamin B12 and Vitamin B6 Against Vincristine Induced Peripheral Neuropathy: A Randomized, Double Blind, Placebo Controlled, Multi Center Trial
This study will be conducted to evaluate the effect of vitamin B12 and vitamin B6 in delaying the onset and reducing the incidence and severity of Vincristine Induced Peripheral Neuropathy (VIPN) in Acute Lymphoblastic Leukemia (ALL) patient.
NCT02923388 — Vincristine Induced Peripheral Neuropathy (VIPN)
Status: Completed
http://inclinicaltrials.com/vincristine-induced-peripheral-neuropathy-vipn/NCT02923388/
Topiramate as a Disease Modifying Therapy for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate as a potential disease modifying therapy for cryptogenic sensory peripheral neuropathy (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do not have an alternative cause for neuropathy will be potentially eligible. The co primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase will last 24 months.
NCT02878798 — Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome
Status: Completed
http://inclinicaltrials.com/cryptogenic-sensory-peripheral-neuropathy-in-metabolic-syndrome/NCT02878798/
Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy (TIPN)
Taxane Induced Peripheral Neuropathy (TIPN) is a major dose limiting side effect of taxane chemotherapies and it often reduces the success of the patient treatment. Treating TIPN is difficult and at this time conventional treatment is primarily limited to the global use of antidepressants and anticonvulsants. Acupuncture treatment has been used for symptom improvement in patients with peripheral neuropathy caused by HIV and diabetes mellitus; however, few studies have evaluated acupuncture as a viable treatment for taxane induced peripheral neuropathy. This study will enroll female breast cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to assess whether acupuncture holds any therapeutic benefit for TIPN and how it influences the mechanisms underlying resolution of TIPN. This would provide critical validation of acupuncture and increase potential for other forms of chemotherapy induced peripheral neuropathy.
NCT02831114 — Peripheral Neuropathy
Status: Completed
http://inclinicaltrials.com/peripheral-neuropathy/NCT02831114/
"Electro Acupuncture in the Treatment and Management of Chemotherapy Induced Peripheral Neuropathy"
To evaluate the effectiveness of Electro acupuncture (EA) for treatment of persistent painful CIPN symptoms in patients with stages 1-3 breast cancer treated with docetaxel chemotherapy 6 months prior
NCT02821442 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT02821442/
The Potential Prophylactic Effect of Exogenous Antioxidant ''L-CARNOSINE'' on Oxaliplatin-induced Peripheral Neuropathy in Cancer Patients
This study evaluates the prophylactic effect of exogenous L-CARNOSINE in Oxaliplatin induced peripheral neuropathy, Thus half of the patients will receive L-CARNOSINE with Oxaliplatin and the other half will not receive L-CARNOSINE with their chemotherapy (oxaliplatin),And then neuropathy together with some oxidative stress markers will be assessed at the end of treatment duration (three months) .
NCT02808624 — Cancer
Status: Completed
http://inclinicaltrials.com/cancer/NCT02808624/
Assessment of the Prevalence of Small Fiber Peripheral Neuropathy Among Non-diabetic Obese Patients
Background / rational: Obesity is associated with significant comorbidities including type 2 diabetes (insulin resistance), heart disease, stroke, hypertension, sleep apnea syndrome, dyslipidemia, cancer, hepatobiliary diseases, orthopedic complications and psychosocial impact 1 . Peripheral neuropathy is a known complication in the type I and II diabetes and glucose intolerance and metabolic syndrome in 2. Outside of diabetes (type I and II) that are associated with cardiovascular risk high vascular, presence of metabolic syndrome constitutes in itself a well demonstrated vascular risk factor. Its definition requires the presence of three elements from the following 5: abdominal obesity (high waist circumference), high blood pressure, high fasting blood sugar, high triglycerides and / low HDL-cholesterol 3. This peripheral neuropathy predominantly affects sensory fibers of small poorly myelinated diameter (Aδ fibers and C) and autonomous sensory fibers and is called small fiber neuropathy 4. The cardinal sign of NAION is the presence of neuropathic pain but abnormalities in physical examination are often absent and conventional electromyography is faulted to make the diagnosis. These small fibers are also constituent of the autonomic nervous system and causes damage autonomic dysfunction that can manifest the cardiovascular system (hypotension, cardiac conduction disorders), digestive, sweat, sphincter. neuropathy of the diagnosis of small fibers is suggested clinically by the presence of neuropathic pain often contrasting with a normal clinical examination. The confirmation is based on electrophysiology with various techniques and quantification of intra-epidermal nerve fibers. Main objective / secondary: Primary objective : To determine the prevalence of a small fiber peripheral neuropathy in nondiabetic obese patients, by measuring skin conductance ion Chlorine (Sudoscan®) evaluating small fibers C autonomic Secondary objectives: - Evaluation of the prevalence of occurrence of peripheral neuropathy by Sudoscan® during follow-up after treatment of obese patients with bariatric surgery (months) M1, 3, 6, 9, 12. - Correlation of results obtained Sudoscan® quantitative sensory testing (QST) Thermotest® evaluating small sensory fibers Aδ, among non-operated non-diabetic obese patients and in the postoperative follow-up (months) M1, 3, 6, 9, 12. - Characterization of electromyographic parameters (motor and sensory conduction) in patients with a skin conductance measured by lowered Sudoscan® and / or a threshold of sensitivity to pain increased Thermotest®. - Correlation between the presence of a small fiber neuropathy in non-diabetic obese subjects with clinical and biological parameters collected. Methodology Design: prospective, single-center Study duration: 24 months (estimate: 3-5 patients included / week of 15 patients collected in central obesity / week) including 12 months of inclusion. Number of topics to include: 100 over a period of one year to adjust to the rhythm of the inclusions. As mentioned, patients will be a measure of impedance of the skin to products chlorine ions by the sweat glands via the Sudoscan®, marketed and used among diabetic patients or not for the detection of violations neuropathic (cf. references and CE certificate attached to the dossier). The Thermotest® is also marketed and used in diabetic and non-diabetic patients (see references and CE certificate attached to the dossier). Our center has gained experience of these techniques for the detection of peripheral neuropathy in several patient populations (diabetes and cancer in particular); manipulators (doctors and technicians) are trained in these techniques.
NCT02767583 — Neuropathology
Status: Completed
http://inclinicaltrials.com/neuropathology/NCT02767583/