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NCT06856447RecruitingPhase 1

The Role of Coenzyme Q10 in the Prophylaxis of Oxaliplatin Induced Peripheral Neuropathy in Patients With Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 4 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study aims to evaluate the possible beneficial role of coenzyme Q10 against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
22 (estimated)
First submitted
3 Jun 2024
Start date
1 Jun 2024
Primary completion date
20 May 2025
Lead sponsor
toqa saad mohammed mohammed
NCT number
NCT06856447

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 22
  • From 1 Jun 2024 to the primary completion date, 20 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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,

Who the study is looking for

  • 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….).

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ain Shams University Hospital
Coordinator of this site? Confirm its status
CairoEgyptRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.