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RECRUITING
NCT06856447
PHASE1

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

Sponsor: toqa saad mohammed mohammed

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2024-06-01

Completion Date

2026-01-10

Last Updated

2025-03-04

Healthy Volunteers

Yes

Interventions

DRUG

Coenzyme 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.

DRUG

Oxaliplatin

Part of the modified FOLFOX-6 chemotherapy regimen

DRUG

5-Fluorouracil (5-FU)

Part of the modified FOLFOX-6 chemotherapy regimen.

DRUG

5-HT3 Antagonist

Used for nausea prevention during chemotherapy.

DRUG

Pantoprazole

Used to prevent gastric irritation during chemotherapy

Locations (1)

Ain-Shams University Hospital

Cairo, Egypt