Neuroprotection of Memantine and Rosuvastatin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Starch Placebo, Memantine, Rosuvastatin 20 Mg Oral Tablet.
- Who it may be relevant to
- Registry conditions: Peripheral Nerve Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neuroprotective Effect of Memantine and Rosuvastatin Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
Overview
Memantine is used to slow the neurotoxicity of Alzheimer disease. Rosuvastatin used as a lipid-lowering agent . Increased bioavailability of endothelial-derived nitric oxide improves endothelium function , increases cerebral blood flow which may all contribute to the neuroprotective effects of rosuvastatin . The goal of this clinical trial is to prevent oxaliplatin induced peripheral neuropathy in patients with colorectal cancer.The aim of this current study is to assess the neuroprotective effect of memantine and rosuvastatin against oxaliplatin induced peripheral neuropathy.
Detailed description
Memantine treatment ameliorated oxaliplatin-elevated intracellular production of reactive oxygen species and lipid product malondialdehyde expression. Memantine alleviated impairment of the mitochondrial membrane potential and ATP production by oxaliplatin Rosuvastatin decreases axonal injury and cortical thickness. Rosuvastatin attenuated the chronic constriction injury induced neuropathic pain and inflammation .Thus, antinociceptive effects of rosuvastatin might be channeled through inhibition of inflammatory biomarkers and antioxidant properties .
Interventions
- Drug Starch Placebo
starch placebo oral tablet will be given to patients plus the modified FOLFOX chemotherapy regimen or XELOX chemotherapy regimen - Drug Memantine
memantine 5 mg PO once daily initially; increased by increments of 5 mg/day each week; maintenance target dosage 20 mg/day - Drug Rosuvastatin 20 Mg Oral Tablet
rosuvastatin 20 mg orally daily.
Primary outcome measures
- The primary outcome is the percentage of patients with sensory neuropathy grade ≥ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events for grading of neuropathy from 1 to 5 based on severity. [Time frame: at base line and every two oxaliplatin cycle (each cycle is 14 days )]
Secondary outcome measures (1)
- the changes in serum levels of the Serum neurofilament light chain as a biomarker of neuronal damage, Serum malondialdhyde as a marker of oxidative stress and Serum tumor necrosis factor alpha as a biomarker of inflammation [Time frame: at base line and after the completion of chemotherapy cycle(6 months)]
Eligibility criteria
Inclusion criteria
- Age above 18 years old for both gender .
- Adequate baseline hematologic values (absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).
- Patients with adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance ˃ 45 mL/min).
- Patients with adequate liver function (serum bilirubin < 1.5 mg/dl).
- Patients with performance status <2 according to Eastern Cooperative Oncology Group (ECOG) score.
- Patients who will be scheduled to receive modified FOLFOX-6 or XELOX regimen.
- Patients with histologically confirmed diagnosis of stage III or stage IV colorectal cancer.
Exclusion criteria
- Children < 18 years old.
- Prior exposure to neurotoxic chemotherapy (oxaliplatin, cisplatin, vincristine, paclitaxel, or docetaxel, INH).
- Patients with diabetes and other conditions that predispose to neuropathy as hypothyroidism, autoimmune diseases, hepatitis C.
- History of known allergy to oxaliplatin or other platinum agents.
- Patients with other inflammatory or stressful conditions.
- Concomitant use of multivitamins (vitamins E, C, A), tricyclic antidepressants, other neuro-protective medications (gabapentin, lamotrigine, carbamazepine and phenytoin).
- Patients on amantadine , acetazolamide, dextromethorphan, aluminum hydroxide magnesium hydroxide and febuxostat .
- Concurrent active cancer originating from a primary site other than colon or rectum.
- Pregnant and breastfeeding women.
- Sever renal insufficiency (creatinine clearance < 25 ml/ minute) .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta — Tanta
Publications
- Ma G, Liu C, Hashim J, Conley G, Morriss N, Meehan WP, Qiu J, Mannix R. Memantine Mitigates Oligodendrocyte Damage after Repetitive Mild Traumatic Brain Injury. Neuroscience. 2019 Nov 21;421:152-161. doi: 10.1016/j.neuroscience.2019.10.016. Epub 2019 Nov 1. PMID 31682950
- Wei G, Gu Z, Gu J, Yu J, Huang X, Qin F, Li L, Ding R, Huo J. Platinum accumulation in oxaliplatin-induced peripheral neuropathy. J Peripher Nerv Syst. 2021 Mar;26(1):35-42. doi: 10.1111/jns.12432. Epub 2021 Jan 27. PMID 33462873
- Zisiadis GA, Alevyzaki A, Nicola E, Rodrigues CFD, Blomgren K, Osman AM. Memantine increases the dendritic complexity of hippocampal young neurons in the juvenile brain after cranial irradiation. Front Oncol. 2023 Oct 4;13:1202200. doi: 10.3389/fonc.2023.1202200. eCollection 2023. PMID 37860190
Identifiers
NCT: NCT07504198 · 36264MS461/12/23