Using Coenzyme Q10 to Prevent Nerve Damage from Oxaliplatin in Colorectal Cancer Patients
The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
This study is testing if coenzyme Q10 can help prevent nerve damage in colorectal cancer patients receiving oxaliplatin chemotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06856447 on ClinicalTrials.gov |
What this trial studies
This study evaluates the potential protective effects of coenzyme Q10 against peripheral neuropathy caused by oxaliplatin in patients diagnosed with colorectal cancer. Oxaliplatin is a commonly used chemotherapy drug that can lead to significant nerve damage, impacting treatment adherence. The trial will involve patients receiving standard chemotherapy regimens, with coenzyme Q10 administered to assess its efficacy in reducing nerve-related side effects. The study aims to improve the quality of life for patients undergoing treatment for colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Stage III colorectal cancer scheduled to receive modified FOLFOX-6 chemotherapy.
Not a fit: Patients with prior exposure to neurotoxic agents within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of painful nerve damage in colorectal cancer patients receiving oxaliplatin.
How similar studies have performed: While there is ongoing research into neuroprotective agents for chemotherapy-induced neuropathy, the specific use of coenzyme Q10 in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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,
Where this trial is running
Cairo
- Ain-Shams University Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: toqa saad mohammed mohammed, master
- Email: toqasaad45@gmail.com
- Phone: 01096266316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.