Clinical trial NCT06570811: Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients
Official title: Effect of Coenzyme Q10 (COQ10) on Chemotherapeutic Toxicity in Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Chemotherapeutic Toxicity
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel study
Primary purpose: TREATMENT

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

Detailed description: 1. Ethical committee approval is obtained from ethics committee of Faculty of Pharmacy, Damanhour University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Forty female patients with newly diagnosed breast cancer who are candidates for will be recruited from Damanhour oncology center.
4. All enrolled patients will be randomly assigned into two arms:

   * Control arm (n=20): will receive 80 mg/m2 of paclitaxel chemotherapy weekly for 4 cycles (12 weeks) after receiving 4 cycles of Adriamycin and cyclophosphamide (AC) protocol
   * Treatment arm (n=20): will receive the same regimen as control arm in addition to Coenzyme Q10 400 mg daily (200 mg twice daily).
5. All patients will be submitted to:

   * Full patient history and clinical examination.
   * Routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests).
   * Assessing the effect of coenzyme Q10 on the following: fatigue, sleep disturbance, peripheral neuropathy, nausea , vomiting , mucositis, Anemia , febrile neutropenia and pruritis using common terminology criteria for adverse event (NCI-CTCAE) version 5.
   * Assessing of the patient's QoL by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity (FACT-GOG-NTx) subscale

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical assessment of the possible effect of COQ10 on some of the expected paclitaxel adverse events using grading system provided by Common Terminology Criteria for Adverse Events (CTCAE) version 5 (V5)
timeFrame: 3 months
measure: The possible impact of COQ10 on peripheral neuropathy affecting patients' quality of life using Neurotoxicity-12 item questionnaire score (Ntx-12) from Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG-Ntx-12)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Oncology Center
Study officials:
affiliation: Ass.professor in clinical pharmacy ,Faculty of pharmacy Damanhour university
name: Amira B Kassem, PhD
role: STUDY_CHAIR
affiliation: Ass.professor in clinical pharmacy ,Faculty of pharmacy Damanhour university
name: Noha Ahmed El Bassiouny, PhD
role: STUDY_CHAIR
affiliation: Lecturer in oncology , Faculty of mediciné Alexandria University
name: Ahmed Ashour, PhD
role: STUDY_DIRECTOR
affiliation: Head of oncology department, Damanhour Oncology Center
name: Yasser Abdelkader
role: STUDY_DIRECTOR
affiliation: Teaching assistant in clinical pharmacy, faculty of pharmacy, Damanhour university
name: Gehad Hassoub, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.