NCT06570811

Coenzyme Q10 and Chemotherapeutic Toxicity in Breast Cancer Patients

Effect of Coenzyme Q10 (COQ10) on Chemotherapeutic Toxicity in Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Fifty female patients with newly diagnosed breast cancer scheduled for weekly paclitaxel chemotherapy (80 mg/m2) will be randomized in a 1:1 ratio. The CoQ10 Group will receive Coenzyme Q10 supplementation (200 mg twice daily) for twelve weeks, while the Control Group will receive standard chemotherapy alone. 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

• Breast Cancer
• Chemotherapeutic Toxicity

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tablets is supplied to breast cancer patients who receive 80 mg/ m2 paclitaxel (taxol®) chemotherapy.
DRUG	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-03-10
• Completion: 2025-03-30
• First posted: 2024-08-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: Egypt