Coenzyme Q10: 100 mg once daily starting after the first chemotherapy cycle. Patients will receive 12 cycles of the modified FOLFOX-6 regimen with Coenzyme Q10 (100 mg once daily in the morning), starting after the first chemotherapy cycle and continuing until the end of the 12th cycle. Based on McRae (2023), 200 mg/day for 12 weeks reduced TNF-α and IL-6; thus, 100 mg/day for 6 months was selected (one cycle every 2 weeks = 24 weeks).
Supportive care: Includes a 5-HT3 antagonist for nausea prevention and pantoprazole to prevent gastric irritation.
Intervention Details:
Oxaliplatin: Part of the FOLFOX-6 regimen. 5-Fluorouracil (5-FU): Part of the FOLFOX-6 regimen. Leucovorin: Part of the FOLFOX-6 regimen. 5-HT3 Antagonist: Used for nausea prevention. Pantoprazole: Used to prevent gastric irritation.
Oxaliplatin: Part of the modified FOLFOX-6 chemotherapy regimen
5-Fluorouracil (5-FU): Part of the modified FOLFOX-6 chemotherapy regimen.
5-HT3 Antagonist: Used for nausea prevention during chemotherapy.
Pantoprazole: Used to prevent gastric irritation during chemotherapy
Study summary
This study aims to evaluate the possible beneficial role of coenzyme Q10 against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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,
Primary outcome measure(s)
Tumor necrosis factor-alpha (TNF-α) — Between 8:30 AM and 10:30 AM after overnight fasting. Blood samples will be collected into a plain test tube and centrifuged at 3,000 revolutions per minute (RPM) for 10 minutes. Tumour Necrosis Factor alpha (TNF alpha), is an inflammatory cytokine produced by macrophages/monocytes during acute inflammation and is responsible for a diverse range of signalling events within cells, leading to necrosis or apoptosis.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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