Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma
Background and objective The introduction of a proteasome inhibitor bortezomib has significantly improved response rates and overall survival in patients with multiple myeloma (MM), and it has soon become the cornerstone of treatment in both newly diagnosed and relapsed/refractory settings. However, the incidence of peripheral neuropathy related to bortezomib (BiPN) is unignorable and which becomes an obstacle during treatment with bortezomib, either alone or in combination. Until now, there are no consistent findings regarding the risk factors that may cause BiPN. There is either lack of large scale study of BiPN in Taiwan. This study aims to clarify risk factors of BiPN using retrospective analysis in a large cohort with longer observation period as well as the relations between BiPN and gene polymorphisms, and to compare different routes in the incidence of BiPN. Methods This is a retrospective cohort study with a sample size of about 400 MM patients treated ever with at least one full cycle of bortezomib in the institution. All the patients enrolled need to be adults (≧20 years ) with measurable M-component in either blood or urine. The investigators will perform a retrospective chart review to collect clinical data, including anti-MM and concomitant medications, to evaluate the incidence and severity of BiPN in this cohort, as well as any meaningful risk factors contributed to BiPN. The investigators also plan to perform genotyping for the possible genetic factors associated with development of BiPN. Expected contributions The successful collaboration between clinical hematologist-oncologist and biopharmaceutical researcher would result in the concrete evidence of efficacy and safety of bortezomib in Taiwanese patients with MM. The findings in this large cohort study will unveil the risk factors of BiPN, including the administration routes and ethnicity. As results, the investigators would be able to provide the precision medicine-based bortezomib treatment strategy to MM patients in Taiwan.
NCT03210753 — Multiple Myeloma
Status: Recruiting
http://inclinicaltrials.com/multiple-myeloma/NCT03210753/
The Effects of Foot and Ankle Joint Mobilisation Combined With a Home Programme of Ankle Stretches on Joint Range of Motion and Forefoot Peak Plantar Pressures in People With Diabetic Peripheral Neuropathy: a Randomized Controlled Trial
Diabetes can affect the blood supply to the nerves in the legs. When this occurs a peripheral neuropathy can occur when the nerves carrying sensory information are affected. People with diabetic peripheral neuropathy have a high risk of foot ulceration and amputation which affects function and associated with high NHS and social care costs. People with diabetes can also have reduced movement at joints caused by increased stiffness in connective tissue. Reductions in ankle and big toe movement leads to increases in the pressure over the sole on the front part of the foot (the forefoot) when walking; this is a risk factor for ulceration. The study will to assess whether ankle and big toe joint mobilisations and home program of stretches in people with diabetic peripheral neuropathy improves joint range of motion and reduces forefoot peak pressures. Fifty eight people with diabetic peripheral neuropathy and a moderate risk of plantar ulceration will be recruited from a local podiatry clinic. They will be randomly assigned to an intervention (29 people) or control group (29 people). We will control for between-group differences in age using a minimization process. The intervention will consist of a 6 week program of ankle and big toe joint mobilisation by a physiotherapist and home stretches. The control group will consist of usual care including podiatry interventions. Outcome measures will be taken at baseline, post intervention and at 3 month follow up by an assessor who does not know the group allocation. Primary outcome will be ankle range while walking with secondary outcomes including big toe joint range, forefoot pressure while walking and balance. Changes over time between the groups will be compared statistically and the relationship between ankle range of motion and peak plantar pressure will be analysed using linear regression.
NCT03195855 — Diabetic Peripheral Neuropathy
Status: Completed
http://inclinicaltrials.com/diabetic-peripheral-neuropathy/NCT03195855/
Acupuncture for Persistent Chemotherapy-induced Peripheral Neuropathy Symptoms in Solid Tumor Survivors: A Pilot Study
The purpose of this study is to compare the effects of real acupuncture with placebo acupuncture or usual care on symptoms of nerve damage from chemotherapy.
NCT03183037 — Peripheral Neuropathy
Status: Completed
http://inclinicaltrials.com/peripheral-neuropathy/NCT03183037/
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
This is a randomized, double-blind, 2-arm, parallel group study of up to 274 evaluable patients designed to evaluate the safety and efficacy of the histone deacetylase 6 (HDAC6) inhibitor ricolinostat for painful DPN.
NCT03176472 — Painful Diabetic Peripheral Neuropathy
Status: Completed
http://inclinicaltrials.com/painful-diabetic-peripheral-neuropathy/NCT03176472/
A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.
NCT03139435 — Stage IV Breast Cancer
Status: Completed
http://inclinicaltrials.com/stage-iv-breast-cancer/NCT03139435/
A Multi-Center, Sham-Controlled, Double-Blind Randomized Withdrawal Study of PEMF Therapy to Evaluate Vibration Perception Threshold and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy in the Lower Extremity
A study to demonstrate the effectiveness of PEMF treatment compared to sham treatment in changing Vibration Perception Threshold (VPT) and Thermal Sensory (QST) in patients with diabetic peripheral neuropathy (DPN) when treatment is administered twice daily through 120-day period.
NCT03077893 — Diabetic Peripheral Neuropathy
Status: Completed
http://inclinicaltrials.com/diabetic-peripheral-neuropathy/NCT03077893/
Effect of Transcranial Direct Current Stimulation on Proprioceptive and Vibratory Sensation: Potential Benefit for Patients With Peripheral Neuropathy
This study will be performed in patients with peripheral neuropathy who are walking independently, but have complains of balance problems such as recent falls or difficulty walking and show reduced vibratory and proprioceptive sensation during routine neurologic examination. These patients will be tested for proprioceptive and vibratory threshold at the toes and ankles before, during and after receiving anodal direct transcranial cortical stimulation (dTCS) over sensory and motor cortices. Subjects will be asked to participate in 2 sessions.
NCT03073759 — Peripheral Neuropathy
Status: Terminated
http://inclinicaltrials.com/peripheral-neuropathy/NCT03073759/
Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
The goal of this research is to develop better tools for diagnosing illness of the feet and legs of people who have diabetes. Investigators will use thermal videos of the foot to aid in the refinement of a system designed to detect signs of diabetic peripheral neuropathy (DPN). The team of investigators will also look at diabetic eye disease and how it might relate to diabetic foot disease.
NCT03069729 — Diabetic Retinopathy
Status: Completed
http://inclinicaltrials.com/diabetic-retinopathy/NCT03069729/
Effects of Electromagnetic Therapy Versus Laser Therapy on Peripheral Neuropathy in Diabetic Patients
This study are to: - Evaluate effect of magnetic therapy on peripheral neuropathy in diabetic patients. - Evaluate effect of laser therapy on peripheral neuropathy in diabetic patients. - Compare effects of magnetic therapy with that of laser therapy on peripheral neuropathy in diabetic patients.
NCT03049605 — Diabetes
Status: Completed
http://inclinicaltrials.com/diabetes/NCT03049605/
Effects of Individually Tailored Whole-body Vibration Training on the Symptoms of Chemotherapy-induced Peripheral Neuropathy: a Randomized-controlled Trial
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control, insecure gait, and higher risk of falling. It is associated with significant disability and poor recovery, not only reducing patients' autonomy and quality of life but also limiting medical cancer therapy, which subsequently may affect the clinical outcome and compromise survival. To date, CIPN cannot be prevented and approved and effective treatment options are lacking. Promising results regarding CIPN have recently been achieved with exercise. Own preliminary work revealed that patients profit from sensorimotor training (SMT), experiencing significant relief from CIPN induced symptoms. In a pilot study we therefore also evaluated whole body vibration training, a further neuromuscular stimulating exercise intervention. Results suggest that whole body vibration (WBV) is not only feasible and safe for neuropathic cancer patients but can attenuate motor and sensory deficits. We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a follow-up period), including 44 patients with neurologically confirmed CIPN, in order to evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the patient reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will include compound muscle action potentials, distal motor latency, conduction velocity, and F-waves from the tibial and peroneal nerve as well as antidromic sensory nerve conduction studies of the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of mm. tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and biceps femoris, peripheral deep sensitivity, proprioception, balance control as well as pain, quality of life and the level of physical activity. Patients will be assessed before and after a 12 week intervention and again after 12 weeks of follow-up. Interim tests will be performed 6 weeks into the intervention as well as every 3 weeks during the follow-up. We hypothesize that individually tailored whole body vibration training will reduce relevant symptoms of CIPN. Our results could contribute to improve supportive care in oncology, thereby enhancing patients' quality of life and coincidentally enabling the optimal medical therapy.
NCT03032718 — Chemotherapy-induced Peripheral Neuropathy
Status: Recruiting
http://inclinicaltrials.com/chemotherapy-induced-peripheral-neuropathy/NCT03032718/