Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients

December 19, 2025 updated by: Damanhour University

Effect of Coenzyme Q10 (COQ10) on Chemotherapeutic Toxicity in Cancer Patients

investigating the potential effect of Coenzyme Q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast cancer patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. The CoQ10 Group will receive Coenzyme Q10 supplementation (200 mg twice daily) for twelve weeks, while the Control Group will receive standard chemotherapy alone.

Safety monitoring for chemotherapy-related toxicities will be conducted using a multi-modal approach. Laboratory assessments, including complete blood counts (CBC) with differential, liver function, and renal function tests, will be obtained at baseline and prior to each weekly treatment cycle. Echocardiography will be performed at baseline and upon completion of the final cycle.

Hematological and non-hematological adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Non-hematological events (including fatigue, neuropathy, and gastrointestinal symptoms) will be captured via structured face-to-face interviews before each chemotherapy session and supplemented by a structured telephone follow-up three days after each session to reduce recall bias. Alopecia and nail changes will be monitored at baseline and at the end of the 12-week chemotherapy course.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Damanhūr, Egypt, 22511
        • Damanhour Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. women with newly diagnosed breast cancer r ≥18 years old.
  2. Naive to chemotherapy.
  3. Eastern Cooperative Oncology Group (ECOG) performance status from 0-2

Exclusion Criteria:

  1. Advanced liver disease (defined as liver enzyme elevation >3-fold upper limit of normality, or cirrhosis); chronic kidney disease (CKD, defined as an estimated glomerular filtration rate (eGFR) <60 ml min-1 1.73 m-2).
  2. Patients with a history of allergy to Coenzyme Q10 and similar compounds.
  3. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication.
  4. Pregnancy or breast feeding.
  5. hereditary muscle disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo Comparator
Placebo Group: 20 patients will receive 80 mg/m2 of paclitaxel chemotherapy weekly for 12 weeks after receiving 4 cycles of AC protocol (Adriamycin and cyclophosphamide)
Drug: Placebo
Placebo tablets is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel (taxol®) chemotherapy.
Experimental: Active Comparator
Coenzyme Q10 Group : 20 patients will receive paclitaxel weekly for 12 weeks after receiving 4 cycles of AC protocol (Adriamycin and cyclophosphamide) in addition to oral 200 mg Coenzyme Q10 twice daily for 3 months.
Drug: Coenzyme Q10 200mg twice daily
400 mg daily (200mg twice daily) of Coenzyme Q10 (an antioxidant that's in many foods, and it's made naturally in the investigator's bodies) is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel (taxol®) chemotherapy.
Other Names:
  • Coenzyme Q10 (Ubiquinol) -200mg ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Time Frame: 3 months

The primary endpoint is Identtifying he number of participants experiencing chemotherapy-related toxicities including fatigue, sleep disturbance, peripheral neuropathy, nausea, vomiting, mucositis, anemia, febrile neutropenia, and pruritus. Grading is based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.The grades as follow

  • Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
  • Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate Instrumental activities of daily living (IADL)
  • Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
  • Grade 4 Life-threatening consequences; urgent intervention indicated.
  • Grade 5 Death
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Chair: Amira B Kassem, PhD, Ass.professor in clinical pharmacy ,Faculty of pharmacy Damanhour university
  • Study Chair: Noha Ahmed El Bassiouny, PhD, Ass.professor in clinical pharmacy ,Faculty of pharmacy Damanhour university
  • Study Director: Ahmed Ashour, PhD, Lecturer in oncology , Faculty of mediciné Alexandria University
  • Study Director: Yasser Abdelkader, Head of oncology department, Damanhour Oncology Center
  • Principal Investigator: Gehad Hassoub, Bachelor, Teaching assistant in clinical pharmacy, faculty of pharmacy, Damanhour university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COQ10 Breast Cancer Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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