Using Coenzyme Q10 to Reduce Chemotherapy Side Effects in Breast Cancer Patients
Effect of Coenzyme Q10 (COQ10) on Chemotherapeutic Toxicity in Cancer Patients
This study is testing if adding Coenzyme Q10 to chemotherapy can help women with newly diagnosed breast cancer feel better by reducing side effects like fatigue and nausea.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Damanhour University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Damanhūr) |
| Trial ID | NCT06570811 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the potential benefits of Coenzyme Q10 in reducing the toxicity associated with paclitaxel chemotherapy in women with newly diagnosed breast cancer. Forty female participants will be randomly assigned to either a control group receiving standard chemotherapy or a treatment group receiving chemotherapy along with Coenzyme Q10. The study will monitor various side effects of chemotherapy, including fatigue, nausea, and neuropathy, as well as assess the overall quality of life of the participants. Ethical approval has been obtained, and all participants will provide informed consent before enrollment.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with newly diagnosed breast cancer who have not yet undergone chemotherapy.
Not a fit: Patients with advanced liver disease, chronic kidney disease, or those with a history of allergy to Coenzyme Q10 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help alleviate the side effects of chemotherapy, improving the quality of life for breast cancer patients.
How similar studies have performed: While the use of Coenzyme Q10 has been explored in various contexts, this specific approach to mitigate chemotherapy toxicity in breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Damanhūr
- Damanhour Oncology Center — Damanhūr, Egypt (Recruiting)
Study contacts
- Principal investigator: Gehad Hassoub, Bachelor — Teaching assistant in clinical pharmacy, faculty of pharmacy, Damanhour university
- Study coordinator: Gehad Hassoub, Demonstrator
- Email: gehadhassoub9@gmail.com
- Phone: 01067457938
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.