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Taking people in EgyptPhase 1

Tests coenzyme Q10 to prevent nerve damage from oxaliplatin in colorectal cancer

Tests coenzyme Q10 for preventing nerve damage in adults with colorectal cancer.

Plain-language title generated from the registry record
Registry title: The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer

Key facts

Where
Cairo, EgyptSee the site
Phase
Phase 1

Where in Egypt

  • Ain Shams University HospitalCairo, EgyptTaking people

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Trial details

Who runs it
toqa saad mohammed mohammed
Trial code
NCT06856447
Record updated
4 March 2025
Original description
This study aims to evaluate the possible beneficial role of coenzyme Q10 against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.Read full original descriptionShow less

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

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

Inclusion: 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: 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,.

ClinicalTrials.gov NCT06856447