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

RecruitingPhase 1Ages 18 Years - anyAlltoqa saad mohammed mohammed
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 18 years old. * Adequate baseline hematologic values (absolute neutrophilic count โ‰ฅ 1.5 ร— 109 /L, platelet count โ‰ฅ 100 ร— 109 /L and hemoglobin level โ‰ฅ 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, etcโ€ฆ.). 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, โ€ฆ. * 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,
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What it tests

  • Coenzyme Q10
  • Oxaliplatin
  • 5-Fluorouracil (5-FU)
  • 5-HT3 Antagonist
  • Pantoprazole
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Where

1 site
Ain-Shams University Hospital
Cairo, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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