Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients

NCT06570811 | Completed Phase 2

• 1 other identifier: COQ10 Breast Cancer Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (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

  3 months

Study Arms (2)

Placebo Comparator

EXPERIMENTAL

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

Active Comparator

EXPERIMENTAL

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

Interventions

Placebo DRUG

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

Placebo Comparator

Coenzyme Q10 200mg twice daily DRUG

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.

Also known as: Coenzyme Q10 (Ubiquinol) -200mg ®

Active Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Female breast cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhour Oncology Center

Damanhūr, 22511, Egypt

Location

Related Publications (4)

• 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.

  PMID: 37199288 BACKGROUND

• 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.

  PMID: 37583905 BACKGROUND

• 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.

  PMID: 22595020 BACKGROUND

• 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.

  PMID: 32601973 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

coenzyme Q10; ubiquinol

Condition Hierarchy (Ancestors)

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

Study Officials

• 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 CHAIR

• Ahmed Ashour, PhD

  Lecturer in oncology , Faculty of mediciné Alexandria University

  STUDY DIRECTOR

• Yasser Abdelkader

  Head of oncology department, Damanhour Oncology Center

  STUDY DIRECTOR

• Gehad Hassoub, Bachelor

  Teaching assistant in clinical pharmacy, faculty of pharmacy, Damanhour university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study where Patients will be classified as follow: Control arm :20 Patients will receive 80 mg/m2 of paclitaxel chemotherapy weekly for 12 weeks after receiving 4 cycles of AC protocol (Adriamycin and cyclophosphamide) Treatment arm : 20 Patients will receive the same regimen as group1 in addition to 200 mg Coenzyme Q10 twice daily for 3 months
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a parallel study

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 26, 2024
• Study Start: August 1, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 30, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)