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New treatment option for Colorectal Cancer
Official title The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer
ClinicalTrials.gov ID: NCT06856447
What this study is testing
What is Coenzyme Q10?
Coenzyme Q10 is an investigational medicine, given as an once-daily, being studied as a potential treatment for colorectal cancer.
Also referred to as Coenzyme Q10 Forte.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the possible beneficial role of coenzyme Q10 against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility 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
- 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,
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.