The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer

Recruiting now · Phase 1

Conditions studied: Colorectal Cancer

In brief

This study aims to evaluate the possible beneficial role of coenzyme Q10 against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.

Key facts

Study ID

NCT06856447

Run by

toqa saad mohammed mohammed

People needed

22

Starts

2024-06-01

Expected to finish

2026-01-10

Last updated by the study team

2025-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with histologically confirmed diagnosis of Stage III colorectal cancer.
• Patients who will be scheduled to receive modified FOLFOX-6.
• Patients with no contraindication to chemotherapy.
• Males and females aged ≥ 18 years old.
• Adequate baseline hematologic values (absolute neutrophilic 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
• Patients with adequate liver function (serum bilirubin < 1.2 mg/dl).
• Patients with performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG) score.
• Patients who may receive medications to counteract chemotherapy induced neuropathic pain (gabapentin, lamotrigine, carbamazepine, etc….).

You may not qualify if…

• Exclusion criteria
• Patients with prior exposure to neurotoxic agents (Cisplatin, vincristine, paclitaxel, docetaxol, foscarnet, INH, etc..) in the last 6 months.
• Patients with evidence of metastasis at the initial assessment.
• Concomitant use of antioxidant vitamins (vitamin A, C, E),
• Preexisting peripheral neuropathy resulting from other causes such as diabetes and brain disorders, hypothyroidism, autoimmune diseases, hepatitis C.
• Patients with diabetes.
• Patients with inflammatory diseases (ulcerative colitis, rheumatoid arthritis).
• Patients with stressful conditions as smoking, COPD, ….
• Patients with active liver disease (cirrhosis, fatty liver, hepatitis C, etc..).
• Patients with myopathy
• Patients with renal impairment, including those with end-stage renal disease and those receiving dialysis.
• Pregnant and breast feeding women.
• Concurrent use of diltiazem, metoprolol, enalapril, nitroglycerin, warfarin, clopidigrel, aspirin, statins, fibrates, tricyclic antidepressant medications,

Where it is running

• Ain-Shams University Hospital — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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