NCT06856447 The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
| NCT ID | NCT06856447 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | toqa saad mohammed mohammed |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 22 participants in total. It began in 2024-06-01 with a primary completion date of 2025-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the possible beneficial role of coenzyme Q10 against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.
Eligibility 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,
Contact & Investigator
Mohamed Reda Kelany, dr
STUDY DIRECTOR
Associate Professor of Clinical Oncology Faculty of Medicine - Ain-Shams University
Frequently Asked Questions
Who can join the NCT06856447 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06856447 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06856447 currently recruiting?
Yes, NCT06856447 is actively recruiting participants. Contact the research team at toqasaad45@gmail.com for enrollment information.
Where is the NCT06856447 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06856447 clinical trial?
NCT06856447 is sponsored by toqa saad mohammed mohammed. The principal investigator is Mohamed Reda Kelany, dr at Associate Professor of Clinical Oncology Faculty of Medicine - Ain-Shams University. The trial plans to enroll 22 participants.
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