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Neuropathy;Peripheral clinical trials

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NCT ID: NCT06422949 Not yet recruiting - Breast Cancer Clinical Trials

Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Taxol is a very effective drug in breast cancer, but it can cause peripheral neuropathy (PN). This toxicity is often dose-limiting. Symptoms of PN usually improve after taxol discontinuation, but >80% of affected women experience symptoms 1-3 years after treatment stop. The intensity, the duration and the type of symptoms related to PN are very different and they can strongly interfere with patients' quality of life. The application of cold to the hands and feet seems to be able to reduce the incidence of PN. Hilotherm® is a machine that allows to cool hands and feet. The aim of this study is to verify whether the use of Hilotherm® is able to reduce the incidence of moderate and severe PN and to evaluate the tolerability of Hilotherm® and its impact on quality of life.

NCT ID: NCT05980767 Recruiting - Clinical trials for Neuropathy;Peripheral

Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

SELECT
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.

NCT ID: NCT05980169 Not yet recruiting - Gynecologic Cancer Clinical Trials

The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the efficacy of SensoniQ® Treatment Station in preventing or reducing chemotherapy induced peripheral neuropathy (CIPN) in patients receiving frontline carboplatin and paclitaxel chemotherapy for a gynecologic malignancy. This study will also assess the improvement of CIPN in patients who have previously received carboplatin and paclitaxel therapy with persistent Grade 2 or worse neuropathy. The main questions this clinical trial aims to answer are: 1. To investigate the efficacy of SensoniQ® Treatment Station on the prevention or reduction of CIPN in gynecologic oncology patients receiving front line carboplatin and paclitaxel. 2. To investigate the efficacy of SensoniQ® Treatment Station on the improvement of existing CIPN in patients who previously received chemotherapy with carboplatin and paclitaxel for a gynecologic malignancy

NCT ID: NCT05624138 Recruiting - Clinical trials for Neuropathy;Peripheral

The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

Start date: November 9, 2022
Phase: Phase 3
Study type: Interventional

The aim of current study is to evaluate the possible protective role of Ketotifen against oxaliplatin-induced peripheral sensory neuropathy in patient with stage III colorectal cancer. This study will be a randomized placebo controlled parallel study.64 patients with colorectal cancer will be randomized to 2 groups: Group I (control group; n=32) which will receive 12 cycles of modified FOLFOX-6 regimen plus placebo tablets twice daily. Group II (ketotifen group; n=32) which will receive modified FOLFOX-6 regimen in addition to ketotifen 2 mg daily Blood sample collection and biochemical assessment: - Serum IL-6 as a marker of inflammation. - Serum superoxide dismutase (SOD) as a biomarker of oxidative stress. - Serum neurotensin as a biomarker for neuropathy. Assessment of oxaliplatin induced peripheral sensory neuropathy will be done through: - The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy at baseline and by the end of every two oxaliplatin cycles. - The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group "FACT/GOG-Ntx-12" at baseline and by the end of every two oxaliplatin cycles. - The assessment of the severity of neuropathic pain through brief pain inventory short form "BPI-SF" worst item. Severity of neuropathic pain will be assessed at baseline and by the end of every two oxaliplatin cycles.

NCT ID: NCT05590117 Enrolling by invitation - Colo-rectal Cancer Clinical Trials

Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal Cancer

Start date: October 11, 2022
Phase: Early Phase 1
Study type: Interventional

This study aims to: - Evaluate the possible protective effect of pentoxifylline against oxaliplatin induced peripheral neuropathy and chemotherapy induced mucositis in patients with stage II and stage III colorectal cancer. This study will be a randomized placebo controlled parallel study.48 patients with colorectal cancer will be randomized to 2 groups: Group I (control group; n=24) which will receive 12 cycles of FOLFOX-6 regimen plus placebo tablets twice daily. Group II (Pentoxiphylline group; n=24) which will receive FOLFOX-6 regimen in addition to pentoxifylline 400 mg twice daily. Blood sample collection and biochemical assessment: - Malondialdehyde (MDA) as oxidative stress marker (colorimetry). - Tumor necrosis factor alfa (TNF-α) as pro inflammatory marker (ELISA). - Neurotensin (NT) as a potential marker for neuropathic pain (ELISA). - Citrulline as a biomarker for mucositis (ELISA). Clinical assessment of oxaliplatin induced neuropathy will be done through: The assessment of the severity of neuropathic pain through "Brief Pain Inventory-Short Form" at baseline and by the end of every two chemotherapy cycles. The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy every 2 cycles. The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group at baseline and by the end of every two chemotherapy cycles). Mucositis will be assessed at baseline and by the end of every two chemotherapy cycles through the use of common terminology criteria for adverse events "CTCAE, version 5.00, 2017

NCT ID: NCT05480527 Recruiting - Clinical trials for Neuropathy;Peripheral

Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Investigators want to investigate the efficacy of transcutaneous pulsed radiofrequency therapy in the treatment of diabetic peripheral neuropathy symptoms. For this purpose, investigators aimed to compare the results of two groups treated with sham electrode and active electrode.

NCT ID: NCT05410548 Completed - Depression Clinical Trials

Comorbidity Screening and Referral by Prosthetists

Start date: June 9, 2022
Phase: N/A
Study type: Interventional

Lower-limb amputation is associated with life-altering and life-limiting comorbidities. Currently, onus is on primary care providers to diagnose, educate, and refer patients for appropriate management. Recently our laboratory has found, however, that of adults post-amputation seen in an outpatient Limb Loss Clinic presenting with comorbidities, >50% are unaware they have signs of peripheral arterial disease and/or neuropathy. Lack of patient awareness and thus, inadequate comorbidity management, may contribute to suboptimal patient outcomes post-amputation. As a first step in this research line, the proposed project will help determine if comorbidity screening by prosthetists during routine care visits for patients post-amputation may enhance comorbidity awareness, increase patient satisfaction in prosthetic services, and reduce gratuitous prosthetic service utilization. During a follow-up visit, seventy patients following a unilateral lower-limb amputation will be randomized into either a standard-of-care group or a standard of-care plus group. The standard-of-care plus group will receive clinical screenings by a certified prosthetist for peripheral arterial disease, peripheral neuropathy, depression, and high-risk for persistent back pain; patient education on findings; and each participant's primary care provider will receive screening results. The long-term goal of this research is to determine if prosthetists can maximize their utility in an interdisciplinary care team, while enhancing patient outcomes post-amputation.

NCT ID: NCT05291975 Recruiting - Clinical trials for Neuropathy;Peripheral

Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain

Start date: February 17, 2022
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to determine the effectiveness of the Erchonia® EVRL™, manufactured by Erchonia Corporation (the Company), in providing prescription home use application for temporary relief of diabetic neuropathy foot pain in individuals diagnosed with diabetic neuropathy by a suitably qualified and licensed health professional.

NCT ID: NCT05291286 Recruiting - Clinical trials for Chemotherapy-induced Peripheral Neuropathy

BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients

RETRO
Start date: October 17, 2022
Phase: Early Phase 1
Study type: Interventional

This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life (QoL) in cancer patients who have been exposed to oxaliplatin and/or taxane-based chemotherapy. This study includes two randomized, placebo controlled, blinded treatment cycles of BXQ-350/placebo, an optional open-label BXQ-350 treatment period, and an unblinded Post-Treatment Follow-up period.