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

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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether Coenzyme Q10 (a natural antioxidant supplement) can help prevent or reduce nerve damage (peripheral neuropathy) — a common and painful side effect of oxaliplatin chemotherapy — in patients with colorectal cancer. **You may be eligible if...** - You are 18 or older (male or female) - You have been diagnosed with Stage III colorectal cancer (confirmed by biopsy) - You are scheduled to receive FOLFOX-6 chemotherapy (which includes oxaliplatin) - Your blood counts, kidney function, and liver function are adequate - Your general health score (ECOG) is 0–1 **You may NOT be eligible if...** - You have been exposed to other nerve-damaging drugs (like cisplatin, vincristine, or paclitaxel) in the last 6 months - You have cancer that has spread to other organs (metastatic disease) - You currently take antioxidant vitamin supplements (A, C, or E) - You already have nerve damage from diabetes, thyroid disease, autoimmune disease, or other causes - You have diabetes or inflammatory conditions like ulcerative colitis or rheumatoid arthritis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Ain-Shams University Hospital

Cairo, Egypt

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NCT06856447


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