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NCT Number: NCT07504198

Neuroprotection of Memantine and Rosuvastatin

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tanta

Tanta, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) .

Treatment and study plan

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.

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Ayman Elsayed Abdallah a Abdallah, Pharm D

CONTACT

[email protected]

022+01285941144

Eman Ibrahim Abd Elkhader El berry i Lecturer of Clinical Pharmacy, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Neuroprotective Effect of Memantine and Rosuvastatin Against Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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