Coenzyme Q10 for Neuroprotection in Paclitaxel-Induced Neuropathy

NCT ID: NCT07307911

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-10
• Study Completion Date: 2026-02-10

Brief 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.

Detailed Description

Fifty female patients with newly diagnosed breast cancer scheduled for weekly paclitaxel chemotherapy (80 mg/m2) will be randomized in a 1:1 ratio into two study arms. The CoQ10 Group will receive Coenzyme Q10 supplementation (200 mg twice daily) for twelve weeks in addition to the standard chemotherapy protocol, while the Control Group will receive the standard chemotherapy protocol alone.

Clinical assessments for peripheral neuropathy, including grading via NCI-CTCAE v5.0, will be conducted prior to the initiation of each weekly paclitaxel session to monitor for symptom onset and severity. Patient-reported outcome measures for neuropathy-specific quality of life (FACT/GOG-Ntx12), fatigue (FACIT-F), and pain intensity (VAS) will be administered at baseline and at the end of weeks 3, 6, 9, and 12. To specifically assess pain interference and severity over time, the Brief Pain Inventory (BPI) will be administered at week 6 and week 12.

For the exploratory biomarker analysis, 5 mL of venous blood will be collected via antecubital venipuncture at baseline (one hour before the first cycle) and one hour after the final paclitaxel dose. Samples will be allowed to clot at room temperature for 30 minutes, then centrifuged at 3,000 rpm for 15 minutes. The resulting serum will be aliquoted and stored at -80 degrees Celsius. Biochemical quantification of NGF, NfL, and OPN will be performed using double-antibody sandwich ELISA, and MDA levels will be determined via colorimetric assay to evaluate oxidative stress and axonal integrity. All participants will be followed for a total of 90 days from the start of treatment to evaluate the time to development of Grade 2 or 3 neuropathy.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Coenzyme Q 10

Intervention Type: DIETARY_SUPPLEMENT

Coenzyme Q10 200 mg orally twice daily for twelve weeks, for CoQ 10 grpup only

Paclitaxel

Intervention Type: DRUG

: Paclitaxel 80 mg/m² administered weekly for twelve weeks to Control and CoQ groups

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.

Group Type: PLACEBO_COMPARATOR

Paclitaxel

Intervention Type: DRUG

: Paclitaxel 80 mg/m² administered weekly for twelve weeks to Control and CoQ groups

Interventions

Coenzyme Q 10

Coenzyme Q10 200 mg orally twice daily for twelve weeks, for CoQ 10 grpup only

Intervention Type: DIETARY_SUPPLEMENT

Paclitaxel

: Paclitaxel 80 mg/m² administered weekly for twelve weeks to Control and CoQ groups

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Pregnancy or breastfeeding.
• Severe cardiovascular disease (left ventricular ejection fraction <55%).
• Hereditary muscle disorders.
• Diabetes mellitus or history of alcoholism.
• Thyroid dysfunction.
• History of allergy to Coenzyme Q10 or related compounds.
• Advanced liver disease (liver enzyme elevation >3× upper limit of normal or cirrhosis).
• Chronic kidney disease (CKD), defined as estimated glomerular filtration rate <60 mL/min/m².

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Damanhur Oncology Center

Damanhūr, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Gehad Fathy Hassoub, Teaching assistant

Role: primary

Other Identifiers

CoQ10-PN-2025-01

Identifier Type: -

Identifier Source: org_study_id