High-dose Vitamin D Supplementation Reduces Inflammation and Improves Microcirculation in Patients With Diabetic Peripheral Neuropathy
Aim. To assess the effect of different doses of vitamin D supplementation on peripheral neuropathy in patients with type 2 diabetes mellitus (T2DM). 68 patients with T2DM and peripheral neuropathy will be randomized into two treatment groups: cholecalciferol 5,000 IU once/week and cholecalciferol 40,000 IU once/week orally for 24 weeks. Severity of neuropathy (neuropathy symptom score (NSS), neuropathy disability score (NDS), visual analog scale (VAS)), body mass index (BMI), glycated hemoglobin (HbA1c), 25-hydroxycalciferol (25(OH)D), parathyroid hormone (PTH), serum interleukins (IL) 1β, 6 and 10, C-reactive protein, tumor necrosis factor α and microcirculation (MC) parameters assessed before and after treatment. The initial and final indicators of the skin blood flow (M, σ, Kv) and MC parameters after postural and occlusal tests by laser Doppler flowmetry (LDF). Sixteen subjects without diabetes will represent the control group.
NCT04377399 — Vitamin D Deficiency
Status: Completed
http://inclinicaltrials.com/vitamin-d-deficiency/NCT04377399/
The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using a Portable Metered-Dose Cannabis Inhaler
Chemotherapy-induced peripheral neuropathy (CIPN) is the most common neurological cancer treatment complication. Medical cannabis is indicated in Israel for the treatment of chronic pain, spasticity and for the control of pain and other symptoms in patients with cancer. The proposed study aims are to study about the changes in level of endocannabinoids following continuous exposure to phytocannabinoids and about the long-term effect of medical cannabis on CIPN.
NCT04376437 — Chemotherapy-induced Peripheral Neuropathy
Status: Not yet recruiting
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT04376437/
Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial
This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by chemotherapy, often called chemotherapy-induced peripheral neuropathy (CIPN). Peripheral neuropathy refers to the conditions that result when nerves that carry messages to and from the brain and spinal cord from and to the rest of the body are damaged or diseased. The TENS device emits high frequency electrical stimulation through the skin and may provide relief from chronic pain.
NCT04367480 — Chemotherapy-Induced Peripheral Neuropathy
Status: Completed
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT04367480/
Position-related Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery - a Comparative Single-center Prospective Cohort Study
This prospective cohort study of patients undergoing colorectal surgery positioned conventionally with shoulder braces was performed. After initial results the implementation of the Pink Pad ® took place in order to compare the two groups. This study favours Pink Pad over conventional positioning concerning postoperative neuropathy.
NCT04343911 — Postoperative Complications
Status: Completed
http://inclinicaltrials.com/postoperative-complications/NCT04343911/
Alpha Lipoic Acid and Diabetes Mellitus: Potential Effects on Peripheral Neuropathy and Different Metabolic Parameters
Patients with type 2 DM who are following will be enrolled into the study. Two visits were scheduled for data collection, physical examination and laboratory testing of the patients: the first prior to initiation of alpha lipoic acid (ALA) administration (baseline visit) and the second at the end of the third month following initiation of ALA (2nd visit).
NCT04322240 — Diabetes Mellitus, Type 2
Status: Completed
http://inclinicaltrials.com/diabetes-mellitus-type-2/NCT04322240/
Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Pain Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (O3NPIQ)
The main objective of this clinical trial is to evaluate the effectiveness and cost-effectiveness of adding ozone therapy to the clinical management of patients with pain secondary to chemotherapy-induced peripheral neuropathy
NCT04299893 — Chemotherapy-induced Peripheral Neuropathy
Status: Recruiting
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT04299893/
A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy
To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers
NCT04237194 — Chemotherapy-induced Peripheral Neuropathy
Status: Recruiting
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT04237194/
Enhancing Functional and Cognitive Performances in People With Amputation and Peripheral Neuropathy Through the Restoration of Sensory Feedback in Real World and Virtual Reality Environments
Many amputees suffer from Phantom Limb Pain (PLP), a condition where painful perceptions arise from the missing limb. Leg amputees wear prostheses that do not provide any sensory feedback, apart from the stump-socket interaction. Increased physical effort associated with prosthesis use as well as discomfort often lead to rejection of artificial limbs. Additionally, the perception of the missing limb and its brain representation, do not match-up with what amputees see (the prosthesis) and this is made worse by the absence of sensory feedback. Therefore, re-establishing the sensory flow of information between the subject's brain and the prosthetic device is extremely important to avoid this mismatch, which creates inadequate embodiment. This study focuses on improving functional abilities and decreasing PLP in amputees thanks to the use of a system able to generate a sensory feedback (SF), which will be provided with a non-invasive electrical stimulation (ES). First, the possibility of enhancing the performance in different functional tasks thanks to the use of SF will be explored. Furthermore, it will be evaluated if SF enhances the prosthesis embodiment and helps restoring a multisensory integration (visuo-tactile), potentially providing also a pain relief. Once tested this system on amputees, also people with peripheral neuropathy and sensory loss will be recruited. Diabetic patients can suffer from symmetrical polyneuropathy (DSPN), which is a common complication caused by prolonged glucose unbalanced levels that lead to nerve damage. Non-invasive ES has been proposed and used as a therapy to treat the chronic pain conditions. In particular, TENS (transcutaneous electrical nerve stimulation) is a type of non-invasive ES, which is able to activate large diameter afferent fibers. The gate control theory of pain states that these large diameter fibers inhibit central nociceptive transmission with a resultant decrease in pain perception. Therefore, also these patients will be recruited to see whether adding a non-invasive SF can enhance their functional motor abilities while diminishing their pain. The subjects will perform a pool of the following tasks, depending on their residual abilities: motor tasks (walking on ground level and on stairs), cognitive tasks (dual tasks), subjective evaluation of prosthesis weight and description of sensations from ES. Some tasks will be performed in Virtual Reality environments with and without an active stimulation.
NCT04217005 — Diabetic Peripheral Neuropathy
Status: Recruiting
http://inclinicaltrials.com/diabetic-peripheral-neuropathy/NCT04217005/
A Phase Ib/II Study of the Safety and Pharmacology of Nilotinib to Prevent Paclitaxel-Induced Peripheral Neuropathy in Patients With Breast Cancer
This phase Ib/II trial studies the side effects and best dose of nilotinib in preventing paclitaxel-induced peripheral neuropathy in stage I-III breast cancer patients who are receiving paclitaxel therapy. Chemotherapy is the usual or ?standard? treatment for breast cancer. It kills cancer cells and lowers the chance that the cancer will come back. Sometimes, this treatment can cause numbness and tingling, especially in the hands and feet. This is called chemotherapy-induced peripheral neuropathy. This study aims to test the safety and effectiveness, both good and bad, of taking nilotinib in preventing chemotherapy-induced peripheral neuropathy.
NCT04205903 — Anatomic Stage III Breast Cancer AJCC v8
Status: Recruiting
http://inclinicaltrials.com/anatomic-stage-iii-breast-cancer-ajcc-v8/NCT04205903/
Safety and Efficacy of High Dose Inorganic seLenium for Preventing Chemotherapy Induced pEripheral Neuropathy in platINUM Sensitive Recurrent Ovarian, Fallopian, Primary Peritoneal Cancer: Phase III Randomised Controlled Trial
This study aims to evaluate the safety and efficacy of high dose inorganic selenium in preventing and relieving chemotherapy-induced peripheral neuropathy (CIPN) in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients. This study will be conducted as a phase III randomized controlled trial in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients who are expected to undergo paclitaxel-carboplatin chemotherapy. A total of 68 patients need to be enrolled in this study. The primary objective of this study is to evaluate the frequency of chemotherapy-induced peripheral neuropathy. The secondary objectives are the evaluation of the severity of peripheral neuropathy and the quality of life to show that selenium is effective in preventing and relieving peripheral neuropathy induced by paclitaxel. Positive results in this study will lead to further studies investigating the effect of selenium on other chemotherapies that can induce peripheral neuropathy.
NCT04201561 — Ovarian Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/ovarian-cancer/NCT04201561/