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Neuroprotection of Memantine and Rosuvastatin

ConditionPeripheral Nerve Disease
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Starch Placebo

    Drug

    starch placebo oral tablet will be given to patients plus the modified FOLFOX chemotherapy regimen or XELOX chemotherapy regimen

  • Memantine

    Drug

    memantine 5 mg PO once daily initially; increased by increments of 5 mg/day each week; maintenance target dosage 20 mg/day

  • Rosuvastatin 20 Mg Oral Tablet

    Drug

    rosuvastatin 20 mg orally daily.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Standard groupPlacebo comparator 1 intervention
Group B: Intervention groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: