RecruitingPhase 1NCT06856447

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

Sponsor

toqa saad mohammed mohammed

Enrollment

22 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria12

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,

Interventions

DRUGCoenzyme Q10

100 mg once daily starting after the first chemotherapy cycle. Patients will receive 12 cycles of the modified FOLFOX-6 regimen with Coenzyme Q10 (100 mg once daily in the morning), starting after the first chemotherapy cycle and continuing until the end of the 12th cycle. Based on McRae (2023), 200 mg/day for 12 weeks reduced TNF-α and IL-6; thus, 100 mg/day for 6 months was selected (one cycle every 2 weeks = 24 weeks). Supportive care: Includes a 5-HT3 antagonist for nausea prevention and pantoprazole to prevent gastric irritation. Intervention Details: Oxaliplatin: Part of the FOLFOX-6 regimen. 5-Fluorouracil (5-FU): Part of the FOLFOX-6 regimen. Leucovorin: Part of the FOLFOX-6 regimen. 5-HT3 Antagonist: Used for nausea prevention. Pantoprazole: Used to prevent gastric irritation.

DRUGOxaliplatin

Part of the modified FOLFOX-6 chemotherapy regimen

DRUG5-Fluorouracil (5-FU)

Part of the modified FOLFOX-6 chemotherapy regimen.

DRUG5-HT3 Antagonist

Used for nausea prevention during chemotherapy.

DRUGPantoprazole

Used to prevent gastric irritation during chemotherapy