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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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,.