Coenzyme Q10 for Neuroprotection in Paclitaxel-Induced Neuropathy

NCT07307911 | Completed Phase 2

• 1 other identifier: CoQ10-PN-2025-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Serum Nerve Growth Factor (NGF) Levels

  Serum NGF levels will be quantified using a double-antibody sandwich ELISA kit to assess neurotrophic status.Unit of Measure: picograms per milliliter (pg/mL).Higher levels are generally associated with nerve repair/regeneration

  Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).

• Change from Baseline in Serum Neurofilament Light Chain (NFL) Levels

  Serum NFL levels will be measured via ELISA as a biomarker of axonal injury and neurodegeneration.Unit of Measure: picograms per milliliter (pg/mL).Higher levels indicate greater degrees of neuronal damage

  Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).

• Change from Baseline in Serum Osteopontin (OPN) Levels

  Serum OPN levels will be quantified using a double-antibody sandwich ELISA kit.Unit of Measure: nanograms per milliliter (ng/mL).low OPN is linked to worse neuropathy.

  Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).

• Change from Baseline in Serum Malondialdehyde (MDA) Levels

  MDA will be measured as a marker of lipid peroxidation and oxidative stress using a colorimetric assay kit.Unit of Measure: nanomoles per milliliter (nmol/mL).Higher levels indicate increased oxidative stress

  Baseline (1 hour before first cycle) and End of Treatment (1 hour after final cycle, approximately Week 12).

Secondary Outcomes (5)

• Incidence of Paclitaxel-Induced Peripheral Neuropathy

  Baseline , week 3, week 6, week 9 and week 12

• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity 12-item questionnaire (FACT/GOG-Ntx12)

  Baseline, week 3, week 6, week 9, and week 12.

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  : Baseline, week 3, week 6, week 9, and week 12.

• Numeric Rating Scale (NRS) for Neuropathic Pain

  Baseline, week 3, week 6, week 9, and week 12.

• Brief Pain Inventory (BPI)-Short Form

  Week 6 and week 12.

Study Arms (2)

CoQ10 group

EXPERIMENTAL

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.

Dietary Supplement: Coenzyme Q 10; Drug: Paclitaxel

Control group

PLACEBO COMPARATOR

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.

Drug: Paclitaxel

Interventions

Coenzyme Q 10 DIETARY_SUPPLEMENT

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

CoQ10 group

Paclitaxel DRUG

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

CoQ10 group; Control group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhur Oncology Center

Damanhūr, 22511, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

coenzyme Q10; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 29, 2025
• Study Start: November 10, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)