Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients
NCT ID: NCT06570811
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2024-08-01
2025-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
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
Study Groups
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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)
Placebo
Placebo tablets is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel (taxol®) chemotherapy.
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.
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.
Interventions
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Placebo
Placebo tablets is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel (taxol®) chemotherapy.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Naive to chemotherapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status from 0-2
Exclusion Criteria
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.
18 Years
70 Years
FEMALE
No
Sponsors
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Damanhour University
OTHER
Responsible Party
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Principal Investigators
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Amira B Kassem, PhD
Role: STUDY_CHAIR
Ass.professor in clinical pharmacy ,Faculty of pharmacy Damanhour university
Noha Ahmed El Bassiouny, PhD
Role: STUDY_CHAIR
Ass.professor in clinical pharmacy ,Faculty of pharmacy Damanhour university
Ahmed Ashour, PhD
Role: STUDY_DIRECTOR
Lecturer in oncology , Faculty of mediciné Alexandria University
Yasser Abdelkader
Role: STUDY_DIRECTOR
Head of oncology department, Damanhour Oncology Center
Gehad Hassoub, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Teaching assistant in clinical pharmacy, faculty of pharmacy, Damanhour university
Locations
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Damanhour Oncology Center
Damanhūr, , Egypt
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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COQ10 Breast Cancer Study
Identifier Type: -
Identifier Source: org_study_id