Coenzyme Q10 for Neuroprotection in Paclitaxel-Induced Neuropathy (Co-Pa-N)

Damanhour University

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Paclitaxel; Dietary Supplement: Coenzyme Q 10

Study type: Interventional

Funder types: Other

Identifiers

NCT07307911

CoQ10-PN-2025-01

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

CoQ10 group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Coenzyme Q 10

Drug: Paclitaxel

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Paclitaxel