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

NCT06856447 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-03-04

No results posted yet for this study

Summary

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

Conditions

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

Sponsors & Collaborators

  • toqa saad mohammed mohammed

    lead OTHER

Principal Investigators

  • Mohamed Reda Kelany, dr · Associate Professor of Clinical Oncology Faculty of Medicine - Ain-Shams University

  • Eman Ibrahim Abd Elkader Elberri · Lecturer of Clinical Pharmacy Faculty of Pharmacy - Tanta University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-05-20
Completion
2026-01-10
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06856447 on ClinicalTrials.gov