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Breast CancerPhase 2NCT06570811

Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients

A Phase 2 study testing Coenzyme Q10 200mg twice daily in people with Breast Cancer and Chemotherapeutic Toxicity, run by Damanhour University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

investigating the potential effect of Coenzyme Q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast cancer patients Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer, Chemotherapeutic Toxicity
What is being tested?
Coenzyme Q10 200mg twice daily
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Aug 2024to 30 Mar 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).
  • Patients with a history of allergy to Coenzyme Q10 and similar compounds.
  • Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication.
  • Pregnancy or breast feeding.
  • hereditary muscle disorders.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Damanhour Oncology Center

    Damanhūr, 22511

Other trials in Egypt

About this study

Official title: 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

Read the 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.

Being tested
Placebo, Coenzyme Q10 200mg twice daily
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo tablets is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel (taxol®) chemotherapy.

  • Coenzyme Q10 200mg twice dailyDrug

    Also called Coenzyme Q10 (Ubiquinol) -200mg ®

    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.

Study groups in NCT06570811
Study groupRoleWhat they receive
Placebo ComparatorExperimentalPlacebo 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)
Receives: Drug: Placebo
Active ComparatorExperimentalCoenzyme 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.
Receives: Drug: Coenzyme Q10 200mg twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

    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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start1 Aug 2024
  3. Primary completion10 Mar 2025
  4. Study completion30 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a parallel study
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570811
Sponsor's protocol ID
COQ10 Breast Cancer Study
Status last verified
Dec 2025
First submitted
9 Aug 2024
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haroun EA, Mansour NO, Eltantawy A, Shams MEE. Effect of cilostazol on preventing paclitaxel-induced neuropathy in patients with breast cancer: A randomized controlled trial. Pharmacotherapy. 2023 Sep;43(9):872-882. doi: 10.1002/phar.2830. Epub 2023 Jun 12.

    PubMed 37199288

  • Bakry HM, Mansour NO, ElKhodary TR, Soliman MM. Efficacy of metformin in prevention of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial. Front Pharmacol. 2023 Jul 31;14:1181312. doi: 10.3389/fphar.2023.1181312. eCollection 2023.

    PubMed 37583905

  • Hernandez-Ojeda J, Cardona-Munoz EG, Roman-Pintos LM, Troyo-Sanroman R, Ortiz-Lazareno PC, Cardenas-Meza MA, Pascoe-Gonzalez S, Miranda-Diaz AG. The effect of ubiquinone in diabetic polyneuropathy: a randomized double-blind placebo-controlled study. J Diabetes Complications. 2012 Jul-Aug;26(4):352-8. doi: 10.1016/j.jdiacomp.2012.04.004. Epub 2012 May 16.

    PubMed 22595020

  • Khalefa HG, Shawki MA, Aboelhassan R, El Wakeel LM. Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study. Breast Cancer Res Treat. 2020 Aug;183(1):117-125. doi: 10.1007/s10549-020-05762-8. Epub 2020 Jun 29.

    PubMed 32601973

  • Hassoub G, El-Bassiouny NA, Abdelkader Y, Badawy AA, Kassem AB. Coenzyme Q10 as an adjunctive strategy to reduce paclitaxel-induced toxicities in breast cancer: a randomized controlled trial. BMC Pharmacol Toxicol. 2026 Jul 4;27(1):95. doi: 10.1186/s40360-026-01163-7.

    PubMed 42401951

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Coenzyme Q10 200mg twice daily in people with Breast Cancer and Chemotherapeutic Toxicity, run by Damanhour University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0 (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06570811, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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