Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT06856447

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

Led by toqa saad mohammed mohammed · Updated on 2025-03-04

22

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed diagnosis of Stage III colorectal cancer.
  • Patients scheduled to receive modified FOLFOX-6 chemotherapy.
  • Patients with no contraindications to chemotherapy.
  • Male and female patients aged 18 years or older.
  • Adequate blood counts: neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 10 g/dl.
  • Adequate kidney function (serum creatinine < 1.5 mg/dl).
  • Adequate liver function (serum bilirubin < 1.2 mg/dl).
  • Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Patients who may receive medications for chemotherapy-induced neuropathic pain (e.g., gabapentin, lamotrigine, carbamazepine).
Not Eligible

You will not qualify if you...

  • Prior exposure to neurotoxic agents (cisplatin, vincristine, paclitaxel, docetaxol, foscarnet, INH) within the last 6 months.
  • Evidence of metastasis at initial assessment.
  • Use of antioxidant vitamins (A, C, E) concurrently.
  • Preexisting peripheral neuropathy from causes such as diabetes, brain disorders, hypothyroidism, autoimmune diseases, hepatitis C.
  • Diagnosis of diabetes.
  • Presence of inflammatory diseases like ulcerative colitis or rheumatoid arthritis.
  • Stressful conditions such as smoking or chronic obstructive pulmonary disease (COPD).
  • Active liver diseases (cirrhosis, fatty liver, hepatitis C).
  • Presence of myopathy.
  • Renal impairment, including end-stage renal disease and dialysis.
  • Pregnant or breastfeeding women.
  • Concurrent use of certain medications including diltiazem, metoprolol, enalapril, nitroglycerin, warfarin, clopidogrel, aspirin, statins, fibrates, or tricyclic antidepressants.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ain-Shams University Hospital

Cairo, Egypt

Actively Recruiting

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Research Team

T

toqa saad mohammed mohammed, master

CONTACT

T

Tarek pro Mostafa mohamed, pro

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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