Overview
investigating the potential effect of Coenzyme Q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast cancer patients
Description
- Ethical committee approval is obtained from ethics committee of Faculty of Pharmacy, Damanhour University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Forty female patients with newly diagnosed breast cancer who are candidates for will be recruited from Damanhour oncology center.
- 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
Inclusion Criteria:
- women with newly diagnosed breast cancer r ≥18 years old.
- Naive to chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0-2
Exclusion Criteria:
- 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.