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Does Riluzole reduce the incidence of chemotherapy-induced nerve injury in patients with colorectal cancer?

ABSTRACT: Interventions: Patients receiving oxaliplatin chemotherapy for colorectal cancer will be randomised into either the study drug arm or placebo control arm. Participants will be started on either riluzole 50 mg oral tablet twice daily or the twice daily lactose placebo tablet. Following randomisation, therapy will be continued for the duration of oxaliplatin treatment (4-6 months) and for 2 weeks following treatment cessation. Primary outcome(s): To assess whether treatment with riluzole results in a reduction in the development of chronic neuropathy and neuropathic symptoms The severity of neuropathy will be assessed using the Total Neuropathy Score (TNS). This will be used to evaluate neuropathy in a number of different categories; sensory neuropathic symptoms, examination findings and nerve conduction results.[Assessed at 6 monthly intervals following randomisation for 2 years] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

DISEASE(S): Neurological-other Neurological Disorders,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Oxaliplatin-induced Neurotoxicity

PROVIDER: 2456970 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Satellite glial GPR37L1 and its ligand maresin 1 regulate potassium channel signaling and pain homeostasis.

Project description:G protein-coupled receptor 37-like 1 (GPR37L1) is an orphan GPCR, and its function remains largely unknown. Here we report that Gpr37l1 and GPR37L1 are among the most highly expressed GPCR transcripts in mouse and human dorsal root ganglia (DRGs) and are selectively expressed in satellite glial cells (SGCs). Peripheral neuropathy following PTX-induced pain resulted in a downregulation of GPR37L1 plasma membrane expression in DRGs. Transgenic mice with Gpr37l1 deficiency exhibited impaired resolution of neuropathic pain symptoms following PTX-induced pain, whereas overexpression of Gpr37l1 in mouse DRGs reversed pain. GPR37L1 regulates the surface expression and function of these potassium channels. Thus, GPR37L1 in SGCs offers a new target for neuropathy protection and pain control.

2024-03-06 | GSE260669 | GEO

Three versus five years of adjuvant Imatinib as treatment for patients with operable gastrointestinal stromal tumour (GIST) with a high risk for recurrence: SSGXXII: A Randomised phase III study

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Comparison of Neurotoxic Potential of Abraxane versus Oxaliplatin and Paclitaxel

Project description:Interventions: Patients receiving abraxane chemotherapy for pancreatic cancer, breast cancer, colorectal cancer, non-small cell lung cancer or ovarian cancer will be recruited into the study to document the natural history of Abraxane-induced neurotoxicity through cross-sectional and prospective clinical and neurophysiological assessment. Examples of neurotoxicity seen with abraxane therapy include sensory dysasthesia including numbness and tingling in the hands and feet. Patients will be assessed monthly from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment, to a maximum period of 2 years following enrolment. Primary outcome(s): To document the natural history of Abraxane-induced neurotoxicity through cross-sectional and prospective clinical and neurophysiological assessment. The severity of neuropathy will be assessed using the Total Neuropathy Score (TNS). This will be used to evaluate neuropathy in a number of different categories; sensory neuropathic symptoms, examination findings and nerve conduction results.[Assessed at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment.] Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

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A Study to Investigate the Safety and Efficacy of TRK-750 for the Treatment of Patients With CIPN (Chopin Study)

Project description:The primary objective of the study is: • to assess the safety and tolerability of multiple oral (twice daily [BID]) doses of TRK-750 in oxaliplatin-treated colorectal cancer patients with chemotherapy-induced peripheral neuropathy (CIPN). The secondary objectives of the study are: * to assess the efficacy of multiple oral (BID) doses of TRK-750 in reducing neuropathic symptoms, improving quality of life (QoL), and clinician-reported outcomes in oxaliplatin-treated colorectal cancer patients with CIPN. * to study the relationship between plasma concentrations of TRK-750 and safety and efficacy variables in oxaliplatin-treated colorectal cancer patients with CIPN. The exploratory objective of this study is: • to assess the efficacy of multiple oral (BID) doses of TRK-750 on pharmacodynamic (PD) biomarker(s) in blood, psychophysical, electrophysiological, and histological parameters of neuropathy in oxaliplatin-treated colorectal cancer patients with CIPN.

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The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy

Project description: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.

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

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2015-10-01 | GSE68049 | GEO

Sex-specific transcriptome of spinal microglia in neuropathic pain due to peripheral nerve injury

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