Neuroprotective Effects of Coenzyme Q10 in Paclitaxel-Induced Peripheral Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

* This study aims to investigate whether Coenzyme Q10 supplementation can reduce chemotherapy-induced peripheral neuropathy, fatigue, and pain in women with newly diagnosed breast cancer receiving paclitaxel treatment. The study will also examine the effects of Coenzyme Q10 on biomarkers associated with nerve damage. The main questions it seeks to answer are: * Does Coenzyme Q10 improve patients' quality of life by reducing neuropathy, fatigue, and pain during chemotherapy? * How does Coenzyme Q10 affect serum levels of nerve growth factor, neurofilament light chain, malondialdehyde, and osteopontin during treatment? * Participants will: Receive either Coenzyme Q10 along with standard weekly paclitaxel chemotherapy or paclitaxel alone for twelve weeks. * Complete questionnaires on neuropathy, fatigue, and pain at the end of each chemotherapy cycle. * Provide blood samples at the beginning and end of the study to measure biomarkers of nerve injury.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Women aged 18 years or older with newly diagnosed breast cancer.

• Chemotherapy-naïve (have not received prior chemotherapy).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Locations
Other Locations
Egypt
Damanhur Oncology Center
RECRUITING
Damanhūr
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2026-02-10
Participants
Target number of participants: 50
Treatments
Experimental: CoQ10 group
Participants in this arm will receive standard weekly paclitaxel chemotherapy (80 mg/m²) for twelve weeks in combination with Coenzyme Q10 supplementation at 200 mg twice daily. The purpose of this arm is to evaluate the effect of Coenzyme Q10 on chemotherapy-induced peripheral neuropathy, fatigue, pain, and related serum biomarkers.
Placebo_comparator: Control group
Participants in this arm will receive standard weekly paclitaxel chemotherapy (80 mg/m²) for twelve weeks without Coenzyme Q10 supplementation. This arm serves as a comparator to evaluate the effects of Coenzyme Q10 on chemotherapy-induced peripheral neuropathy, fatigue, pain, and related serum biomarkers.
Related Therapeutic Areas
Sponsors
Leads: Damanhour University

This content was sourced from clinicaltrials.gov