Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients

Phase 2

Recruiting

• Conditions: Breast Cancer; Chemotherapeutic Toxicity

• Registration Number: NCT06570811
• Lead Sponsor: Damanhour University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:<br><br> 1. women with newly diagnosed breast cancer r =18 years old.<br><br> 2. Naive to chemotherapy.<br><br> 3. Eastern Cooperative Oncology Group (ECOG) performance status from 0-2<br><br>Exclusion Criteria:<br><br> 1. Advanced liver disease (defined as liver enzyme elevation >3-fold upper limit of<br> normality, or cirrhosis); chronic kidney disease (CKD, defined as an estimated<br> glomerular filtration rate (eGFR) <60 ml min-1 1.73 m-2).<br><br> 2. Patients with a history of allergy to Coenzyme Q10 and similar compounds.<br><br> 3. Concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other<br> neuropathic pain medication.<br><br> 4. Pregnancy or breast feeding.<br><br> 5. hereditary muscle disorders.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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);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)