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The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
RECRUITINGPhase 1Sponsored by toqa saad mohammed mohammed
Actively Recruiting
PhasePhase 1
Sponsortoqa saad mohammed mohammed
Started2024-06-01
Est. completion2025-05-20
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06856447
Summary
This study aims to evaluate the possible beneficial role of coenzyme Q10 against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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….). Exclusion Criteria: * 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,
Conditions2
CancerColorectal Cancer
Interventions5
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Actively Recruiting
PhasePhase 1
Sponsortoqa saad mohammed mohammed
Started2024-06-01
Est. completion2025-05-20
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06856447